The Medical Device Reporting (MDR) dataset lists the Center for Devices and Radiological Health CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1984 through 1996.
John Snow Labs Standard End User License Agreement
Last updated:January 20, 2021
This Standard End User License Agreement (“EULA”) applies to customers of John Snow Labs Inc. (as defined below), using any product of John Snow Labs Inc. on John Snow Labs Marketplace as defined below (hereinafter referred to “you”) and John Snow Labs Inc., a Delaware corporation (“John Snow Labs”, “we” or “us”).
By downloading, installing, and/or using (as applicable) any Product of John Snow Labs (as defined below), you automatically agree to be bound by, and use our Products in compliance with, this EULA. This EULA, together with additional terms and conditions and/or policies referenced herein or located on https://www.johnsnowlabs.com and/or conveyed to you by John Snow Labs, is a legally binding contract between you and John Snow Labs.
PLEASE READ THIS EULA CAREFULLY BEFORE PURCHASING, INSTALLING OR USING OUR PRODUCTS MADE AVAILABLE ON JOHN SNOW LABS MARKETPLACE.
We may make changes to this EULA from time to time. When we do so, we will revise the “last updated” date given above. The then-current version of this EULA will supersede all earlier versions. You agree that your continued use of our Products after such changes have been published to our EULA will constitute your acceptance of such revised EULA.
“Products” means products and services of John Snow Labs that you download and use from listings in John Snow Labs Data Library;
Important Notice
By installing and using our Products, you acknowledge that the use of the Products can be subject to the restrictions and controls imposed by United States export regulations.
You represent and warrant that you do not intend to use the Products for any purpose prohibited by United States export regulations, including, without limitation, terrorism, cyber-attacks, cyber-crimes, money-laundering, industrial espionage, or nuclear, chemical or biological weapons proliferation. Further, you represent and warrant that you are not listed as a denied party on any list governing United States exports.
Eligibility
Our Products can be used by an individual, business or other legal entity, or both. If you are entering into this EULA, or using the Products, on behalf of a company or other legal entity, you represent that you have the authority to bind such entity to this EULA, in which case “you” shall refer to such entity.
In the event you have entered into a separate written agreement with John Snow Labs regarding the Products that contemplates terms that are inconsistent with this EULA, the written agreement shall control and this EULA will not apply to you to the extent inconsistent with such written agreement, or, if such written agreement is contemplated to be in lieu of this EULA, then this EULA shall not apply at all.
Your Access and Use
Subject to your compliance with this EULA, as well as any other applicable policies, John Snow Labs grants you non-exclusive, non-transferable, license to install, access to, modify, and use of, the Products worldwide (subject to applicable export laws) during the term of this EULA (as described below) solely for research, private study and personal use of Products.
This license is personal to you, and you may not resell our Products, permit other users access to our Products through your account. Your right to use our Products is limited by all terms and conditions set forth in this EULA.
Except for your pre-existing rights and this license granted to you, we and our licensors retain all rights, titles and interests in and to our Products, all related intellectual property rights, including trademarks (whether registered or pending), domain and business names. Our Products are protected by applicable intellectual property laws, including United States copyright law and international treaties.
Except for the foregoing license, you have no other rights in the Products and you may not modify, edit, copy, reproduce, create derivative works of, reverse engineer, alter, enhance or in any way exploit the Products in any manner. If you breach any of this EULA, the above license will terminate automatically.
You will be deemed to have taken any action that you permit, assist or facilitate any person or entity to take related to this EULA, your content or use of the Products. You are responsible for end users’ use of your content and the Products. You will ensure that all end users comply with your obligations under this EULA and that the terms of your agreement with each end user are consistent with this EULA. If you become aware of any violation of your obligations under this EULA caused by an end user, you will immediately suspend access to your content and the Products by such end user. We do not provide any support or services to end users unless we have a separate agreement with you or an end user obligating us to provide such support or services.
Restrictions
You will access or use our Products solely via John Snow Labs Data Library.
Except as otherwise explicitly provided in this EULA or as may be expressly permitted by applicable law, you will not, and will not permit or authorize any third party to:
reproduce, modify, translate, enhance, decompile, disassemble, reverse engineer or create derivative works of any of our Products or its technological features or measures;
rent, lease, sell, resell, loan, distribute, or sublicense access to any of our Products;
circumvent or disable any security or technological features or measures of our Products;
use our intellectual property rights without our express prior written authorization;
use our Products for more than one trial period, unless the trial period is extended by John Snow Labs’ prior written permit;
use our Products with an intent to build a competitive product or service, or copy or substantially copy any ideas, features, functions, organization, structure, application program interface, graphics, or user interface of the Products;
store, copy, modify, distribute, or resell any of the information; audio, visual, and audiovisual works, or other content made available on our Products (collectively, “Content”) or compile or collect any Content as part of a database or other work;
use any automated tool (e.g., robots, spiders) to access or use our Products, or to store, copy, modify, distribute, or resell any Content;
circumvent or disable any rights management, usage rules, or other security features of our Products;
use our Products in a manner that overburdens, or that threatens the integrity, performance, or availability of, our Products; or
remove, alter, or obscure any proprietary notices (including copyright and trademark notices) on any portion of our Products or any Content.
Fees and Taxes
Your use of the Products is subject to our fees. All fees are given on our website https://www.johnsnowlabs.com. Except as set forth in this EULA, the fees are non-refundable. We are entitled to revise our fees from time to time.
The fees exclude any federal, state or local taxes, VAT, GST, or similar taxes. You are responsible for identification and payment of all taxes as required by applicable law.
Term and Termination
This EULA will become effective as of the date of your order of Products and shall be in effect until terminated.
John Snow Labs may suspend or terminate your right to use our Products, if you or your end user’s use of the Products:
is in breach of this EULA;
poses a security risk to our Products;
could adversely impact our systems, the Products or other customers;
could subject us, our affiliates, or any third party to liability; or
could be fraudulent.
We may also suspend or terminate your right to use our Products, if you fail to perform your payment obligations, or you have ceased to operate in the ordinary course, made an assignment for the benefit of creditors or similar disposition of your assets, or become the subject of any bankruptcy, reorganization, liquidation, dissolution or similar proceeding.
We may also suspend or terminate your right to use our Products without any reason upon a relevant 30 days’ written notice to you and will refund the unused fees pre-paid by you for access to the Products for the affected time period (if any). Where your access is suspended or terminated by the breach of this EULA or applicable laws, John Snow Labs will will not provide, or be liable for, any refund.
You will cease use of the Products during any period of suspension, or upon termination of this EULA.
All provisions which by their nature are intended to survive termination shall survive termination of this EULA.
Support
If applicable to your Product, John Snow Labs will provide you with the support services. If you use a trial access, support services are excluded. Under this EULA, our support services exclude any installation, training, maintenance services (including any error corrections, bug fixes, or new releases), technical assistance, consulting services, or other services of any kind. Such services are provided at John Snow Labs’ discretion.
From time to time John Snow Labs can perform updates to our software. If available, such updates may include bug fixes, new features and/or enhancements. You are solely responsible for deploying such updates at your own risk and liability.
Access to our Products
We do not provide you with the equipment to access our Products. You are responsible for all fees charged by third parties related to your access and use of our Products (e.g., charges by Internet service providers).
You are responsible for monitoring your use of the Products, including payment of all fees and/or taxes related to such access and use. You agree that John Snow Labs is permitted to request and you hereby consent to provide John Snow Labs information related to your use of the Products for auditing purposes.
You also certify that you are legally permitted to use the Products, and take full responsibility for the selection and use of the Products. This EULA is void where prohibited by law, and the right to use the Products is revoked in such jurisdictions. John Snow Labs makes no claim that the Products may be lawfully used outside of the United States. If you use the Products from outside of the United States, you do so at your own risk and you are responsible for compliance with the laws of jurisdiction.
Privacy Policy
We may collect, store and receive personal and other information about you through our Products. Our collection and use of this information is governed by our Privacy Policy available at https://www.JohnSnowLabs.com/privacy/ which may be amended from time to time.
Links and Third Party Content
Our Products may display, or contain links to, third party products, services, and websites. Any opinions, advice, statements, services, offers, or other information that constitutes part of the content expressed, authored, or made available by other users or other third parties, or which is accessible through or may be located using our Products (collectively, “Third Party Content”) are those of the respective authors or producers and not of us or our shareholders, directors, officers, employees, agents, or representatives.
We do not control Third Party Content and do not guarantee the accuracy, integrity or quality of such Third Party Content. We are not responsible for the performance of, we do not endorse, and we are not responsible or liable for, any Third Party Content or any information or materials advertised in any Third Party Content. By using our Products, you may be exposed to content that is offensive, indecent, or objectionable. We are not responsible or liable, directly or indirectly, for any damage or loss caused to you by your use of or reliance on any goods, services, or information available on or through any third party service or Third Party Content. It is your responsibility to evaluate the information, opinion, advice, or other content available on and through our Products.
Proprietary Rights
John Snow Labs will not obtain any rights under this EULA from you (or your licensors) to your content.
The Products, including software, is and remains the exclusive property of John Snow Labs and its licensors. Except for the access and use rights expressly set forth in this EULA, no license or other rights in or to the Products or John Snow Labs trademark(s) and other intellectual property rights therein, are granted to you, and all such licenses and rights are expressly reserved. You will not remove, alter, or obscure any proprietary notices (including copyright and trademark notices) on any portion of our Products or any Content.
Trademarks
“John Snow Labs,” the John Snow Labs logo, and any other product, business or service name or slogan, whether registered or pending, displayed on our Products are trademarks of John Snow Labs, Inc. or its suppliers or licensors, and may not be copied, imitated or used, in whole or in part, without the prior written permission of John Snow Labs or the applicable trademark holder. You may not use any metatags or any other “hidden text” utilizing “John Snow Labs” or any other name, trademark or product, business or service name of John Snow Labs without our prior written permission. In addition, the look and feel of our Products, including all page headers, custom graphics, button icons and scripts, is the service mark, trademark and/or trade dress of John Snow Labs and may not be copied, imitated or used, in whole or in part, without our prior written permission. All other trademarks, pending trademarks, registered trademarks, product names and company names or logos mentioned in our Products are the property of John Snow Labs Inc. and/or their respective owners. Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier, or otherwise does not constitute or imply endorsement, sponsorship, or recommendation thereof by us.
Disclaimer of Warranties
YOUR USE OF THE PRODUCTS IS AT YOUR SOLE RISK. THE PRODUCTS AND CONTENT EACH ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. WE AND OUR SUPPLIERS AND LICENSORS EXPRESSLY DISCLAIM ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. WE DO NOT GUARANTEE THE ACCURACY, COMPLETENESS, OR USEFULNESS OF THE PRODUCTS OR ANY CONTENT, AND YOU RELY ON THE PRODUCTS AND CONTENT AT YOUR OWN RISK. ANY MATERIAL THAT YOU ACCESS OR OBTAIN THROUGH OUR PRODUCTS IS DONE AT YOUR OWN DISCRETION AND RISK AND YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY MATERIAL THROUGH OUR PRODUCTS. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM US OR THROUGH OR FROM OUR PRODUCTS WILL CREATE ANY WARRANTY NOT EXPRESSLY STATED IN THIS EULA. SOME STATES MAY PROHIBIT A DISCLAIMER OF WARRANTIES AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE.
Limitation of Liability
WE AND OUR SUPPLIERS AND LICENSORS WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF THESE DAMAGES), RESULTING FROM YOUR USE OF OUR PRODUCTS AND CONTENT. UNDER NO CIRCUMSTANCES WILL THE TOTAL LIABILITY OF US AND OUR SUPPLIERS AND LICENSORS OF ALL KINDS ARISING OUT OF OR RELATED TO YOUR USE OF THE PRODUCTS AND CONTENT (INCLUDING BUT NOT LIMITED TO WARRANTY CLAIMS), REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR OTHERWISE, EXCEED THE AMOUNTS, IF ANY, THAT YOU HAVE PAID FOR YOUR USE OF THE PRODUCTS AND CONTENT. BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.
Indemnity
To the full extent permitted by applicable law, you shall defend, indemnify and hold harmless John Snow Labs, its affiliates and its licensors, and each of their respective employees, officers, directors, and representatives from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorney’s fees) arising out of or relating to any third party claim concerning: (a) your use of the Products; (b) breach of this EULA or violation of applicable law by you; (c) any content or the combination of such content with other software, content or processes, including any claim involving alleged infringement or misappropriation of third-party rights by such content or combination; or (d) breach of any obligation or duty you owe to a third party.
Legal Notices
Enforcement of this EULA will be governed by the laws of the State of Delaware, excluding its conflict and choice of law principles. The exclusive jurisdiction and venue for any claims arising out of or related to this EULA or your use of the Products will lie in the state and federal courts located in Sussex County, within the State of Delaware, and you irrevocably agree to submit to the jurisdiction of such courts. Our failure to enforce any right or provision in this EULA will not constitute a waiver of such right or provision unless acknowledged and agreed by us in writing. In the event that a court of competent jurisdiction finds any provision of this EULA to be illegal, invalid, or unenforceable, the remaining provisions will remain in full force and effect.
Notifications
We may use your contact information to notify you if we have any legitimate interest or if we need to notify you on any important information related to your use of Products. We will not send you newsletters unless you expressly consented to such notifications.
Contacting Us
If you have any questions or concerns about our Products or this EULA, you may contact us by email at support@JohnSnowLabs.com.
The Medical Device Reporting dataset contains information from CDRH’s device experience reports on devices which may have malfunctioned or caused a death or serious injury.
The dataset contains reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 – 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.
The FDA is required under the Freedom of Information and Privacy Acts (SEC 552, Title 5, USC) (PL 93-579) to delete, prior to public disclosure, any information that constitutes trade secrets, and confidential, commercial, or financial information; and any personal, medical and similar information that would constitute a clearly unwarranted invasion of personal privacy. Included in the deletion requirements are all identification of the reporters of the events.
About this Dataset
Data Info
Date Created
1997
Last Modified
1997-12-02
Version
1997-12-02
Update Frequency
Never
Temporal Coverage
1984 to 1996
Spatial Coverage
United States
Source
John Snow Labs; U.S. Food and Drug Administration (FDA);
Source License URL
Source License Requirements
N/A
Source Citation
N/A
Keywords
MAUDE, Device Experience, MAUDE Manufacturer Reports, MDR, Medical Device Events, Medical Device Deaths
Other Titles
Medical Devices Adverse Events, Medical Devices Adverse Events Reports, Medical Devices Experience Reports
Data Fields
Name
Description
Type
Constraints
Access_Type_And_Number
the report access number
string
required : 1
Date_Received
Received Date
date
required : 1
Product_Description
Event product description
string
-
Manufacturer_Name_Code
Product manufacturer name code
string
required : 1
Manufacturer_Name
Product manufacturer name
string
-
Street_Address
Product manufacturer Street Address
string
-
City
Product manufacturer City
string
-
State
Product manufacturer State
string
-
Zipcode
Product manufacturer Zip code
string
-
Report_Type
Report type, varies from malfunction to death
string
-
Model_Number
Medical device model number
string
-
Catalog_Number
Catalog number
string
-
FDA_Panel_Code
FDA panel code
string
-
FDA_Product_Code
FDA product code
string
required : 1
Event_Description_Type
Precise if Event description type is preliminary or final
string
-
Event_Description
Description of the event linked to the medical device
string
-
Closeout_Text
Other important comments
string
-
Data Preview
Access Type And Number
Date Received
Product Description
Manufacturer Name Code
Manufacturer Name
Street Address
City
State
Zipcode
Report Type
Model Number
Catalog Number
FDA Panel Code
FDA Product Code
Event Description Type
Event Description
Closeout Text
M765683
1997-01-03
ARTIFICIAL URINARY SPHINCTER
AMERMEDISYST
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA
MN
55343
SERIOUS INJURY
800
GASTROENTEROLOGY-UROLOGY
EZY
FINAL
THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO RECURRING INCONTINENCE. OTHER RELEVANT HISTORY, INCLUDES POST PROSTATECTOMY AND POST TUR; TURP; TURS. IMPLANT DATE IS 12/27/95. EXPLANT DATE IS 2/5/96.
IMPLANTABLE CARIOVERTER DEFIBRILLATOR (ICD) HAS BEEN IDENTIFIED AS POSSIBLY CONTAINING RESIDUAL GASES (ARGON AND HELIUM) WHICH SHOULD HAVE BEEN REPLACED WITH NITROGEN DURING THE MANUFACTURING PROCESS. THIS COULD CAUSE ELECTRICAL STRESS DAMAGE DURING THE SERVICE CHARGING PROCESS. DR WAS NOTIFIED AND THE PT WAS BROUGHT IN FOR TESTING. THREE CAPACITOR REFORMS WERE PERFORMED, DEFIBRILLATION THRESHOLDS RE-TESTED, AND NORMAL DEVICE WAS OPERATION WAS CONFIRMED. DR ELECTED TO LEAVE THE DEVICE IMPLANTED AT THIS TIME. THE DR WILL PERFORM MANUAL CAPACITOR REFORMS. THE NORMAL FOLLOW-UP SCHEDULE WILL BE FOLLOWED. THIS EVENT WAS REPORTED AFTER REVIEW OF RECORDS SHOWS THAT THE EVENT HAD NOT BEEN REPORTED EARLIER. THE DEVICE WAS TESTED AND OPERATES WITHIN SPEC AT THIS TIME.
M885680
1997-01-04
REDY 2000
GAMBHEAL
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD
CO
80215
MALFUNCTION
REDY 2000
604487-006
GASTROENTEROLOGY-UROLOGY
FKP
FINAL
AT THE BEGINNING OF A DIALYSIS TREATMENT, THE FACILITY NOTICED THAT THE "TOTAL UF (ULTRAFILITRATION) WAS NOT READING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS ORIGINALLY REPORTED TO THE MFR ON 5/23/96, HOWEVER, THE MFR DETERMINED ALL RELATED COMPLAINTS TO BE MDR REPORTABLE AFTER THE NEW MDR REGULATIONS TOOK INTO EFFECT. THIS MDR WAS ALSO NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD. DEVICE DISCARDED-UNABLE TO FOLLOW-UP. THE MEDICAL EQUIPMENT SERVICE TECH (MES) REPLACED THE LOAD CELL AND CALIBRATED TO MANUFACTURING SPECS. THERE WERE NO RELATED CPF DEFECTS REPORTED ON THIS MACHINE. THE AFFECTED LOAD CELL ASSEMBLY WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE THE MES DISCARDED IT UPON REPLACEMENT. WITHOUT THE AFFECTED COMPONENT AN EVALUATION AS TO THE FAILURE MODE COULD NOT BE DETERMINED. IF THE LOAD CELL WAS DEFECTIVE A LOAD CELL CIRCUIT ALARM WOULD BE GENERATED. THIS ALARM CONSISTS OF A STEADY AUDIBLE ALARM, THE TOTAL UF DISPLAY FLASHES, THE ULTRAFILTRATION CONTROL IS DISABLED, AND THE MACHINE ENTERS BY-PASS AS STATED IN THE DEVICE. IF THE MACHINE DOES NOT FIND A DEFECT IN THE LOAD CELL CIRCUIT THIS ALARM WILL NOT BE GENERATED. HOWEVER, ANY FLUCUATIONS IN THE LOAD CELL DURING A TREATMENT WILL BE NOTICED IN THE UF RATE. HOWEVER, ANY FLUCUATIONS IN THE LOAD CELL DURING A TREATMENT WILL BE NOTICED IN THE UF RATE. IF THE LOAD CELL STOPPED READING AT A CERTAIN POINT THE UF CIRCUIT WOULD TRY TO COMPENSATE AND THE UF RATE WOULD INCREASE. IF THE UF RATE DOES NOT STOP INCREASING THE MACHINE WOULD GENERATE A HIGH UF RATE ALRM. IN THIS INCIDENT, FOR AN UNKNOWN REASON, THE UF RATE STOPPED INCREASING, THERFORE THE ALARM DID NOT OCCUR. THE UF RATE ALARM ENTAILS A STEADY AUDIBLE ALARM AND THE MACHINE ENTERS THE BY-PASS MODE. AS STATED IN THE DEVICE. (*)
M885681
1997-01-15
COBE CENTRYSYSTEM 3
GAMBHEAL
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD
CO
80215
MALFUNCTION
333100-001
GASTROENTEROLOGY-UROLOGY
FII
FINAL
DURING A DIALYSIS TREATMENT, A FOUR POSITION LINE CLAMP BROKE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THIS MDR WAS ORIGINALLY REPORTED TO THE MFR ON 6/5/96. HOWEVER, THE MFR HAS DETERMINED THIS COMPLAINT TO BE MDR REPORTABLE AFTER THE NEW REGULATIONS TOOK INTO EFFECT. THIS MDR WAS ALSO INADVERTENTLY NOT REPORTED WITHIN THE ALLOTED TIME PERIOD. DEVICE FAILURE DIRECTLY CAUSED EVENT. THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. THE FOUR-POSITION LINE CLAMP WAS NOT RETURNED FOR AN INVESTIGATION BECAUSE IT WAS DISCARDED UPON REMOVAL, IT INDICATES THAT THE TABS ON THE WHITE CLAMP INSERT HOLDER WERE BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE REPORTED CLAMP'S STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE OPERATOR'S MANUAL RECOMMENDS THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLED CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN THE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO THE PT CAN RESULT. (*)
M885685
1997-01-06
GUARDIAN
GUARPROD
GUARDIAN PRODUCTS
4175 GUARDIAN ST.
SIMI VALLEY
CA
93063
MALFUNCTION
30756P
30756P
PHYSICAL MEDICINE
ITJ
FINAL
USER CLAIMS THAT WALKER LEG SNAPPED. FOUND AS A RESULT OF INTERNAL AUDIT OF COMPLAINT FILES. FAILURE MODE DETERMINED TO BE DUCTILE DUE TO IMPACT - NOT A FATIGUE FAILURE. WALKER WILL NOT SEE ANY IMPACT IN ANY NORMAL OR HEAVY USE. DETERMINATION IS THAT FAILURE OCCURED DUE TO ABNORMAL USE OR ABUSE. VERY POSSIBLE THAT USER LOST BALANCE AND FELL ON UNIT. STIFFENING INSERT IMPROVED IN ATTEMPT TO STRENGTHEN THIS AREA BEYOND ITS NORMAL INTENDED USE REQUIREMENT. TYPE OF REPORTABLE EVENT: BRUISE.
M765746
1997-01-21
SIDEKICK II
PRIDHEALCARE
PRIDE HEALTH CARE, INC.
182 SUSQUEHANNA AVE
EXETER
PA
18643
SERIOUS INJURY
SC213
SC213
PHYSICAL MEDICINE
INI
FINAL
ENDUSER CLAIMS SHE FELL OFF SCOOTER TWO OR THREE TIME INJURING HER NECK. SHE IS NOW WEARING A BRACE. A REP WAS SENT TO THE PTS HOME TO EVALUATE THE DEVICE. THE REP TESTED THE DEVICE UNDER THE CONDITIONS INDICATED BY THE USER AND COULD NOT DUPLICATE THE EVENT. NO REMEDIAL ACTION WAS TAKEN.
M765745
1997-01-21
PRIDE GENTLE LIFT RECLINER
PRIDHEALCARE
PRIDE HEALTH CARE, INC.
182 SUSQUEHANNA AVE
EXETER
PA
18643
SERIOUS INJURY
GENERAL HOSPITAL
FSA
PRELIMINARY
FELL OUT OF LIFT CHAIR. FRACTURED LUMBER. THIS IS AN EVENT THE CHAIR HAS INVOLVED BUT ALL INDICATIONS ARE THAT THE CHAIR WAS NOT THE ROOT CAUSE OF THE EVENT. MANUFACTURE DATE: 6/15/94.
M765760
1997-01-22
SILASTIC (R) MAMMARY PROSTHESIS
DOWCORN
DOW CORNING CORP.
2200 WEST SALZBURG ROAD
AUBURN
MI
48611
SERIOUS INJURY
UNK
GENERAL AND PLASTIC SURGERY
FTR
FINAL
PT ALLEGES HAVING A BAD INFECTION IN 1971, HER BREASTS HAVE GOTTEN HARDER, SHE HAS FIBROUS TISSUE, HAS BEEN DIAGNOSED WITH AUTOIMMUNE DISEASE, HAS THYROID CANCER, HER GALLBLADDER WAS REMOVED, SHE HAD A HYSTERECTOMY AND A LIVER TRANSPLANT. PT ALSO ALLEGES DUE TO HER LIVER TRANSPLANT, SHE IS UNABLE TO HAVE REMOVAL OF HER IMPLANTS. ATTY ALLEGES PT'S PHYSICAL INJURIES INCLUDE CHRONIC FATIQUE, BURNING OR ACHING IN THE BREAST AREA, HEADACHES, RECURRENT FLU-LIKE SYMPTOMS, MENTAL ANGUISH, FEAR, PAIN AND DISFIGUREMENT.
M765759
1997-01-22
SILASTIC (R) MSI MAMMARY IMPLANT, H.P.
DOWCORN
DOW CORNING CORP.
2200 WEST SALZBURG ROAD
AUBURN
MI
48611
SERIOUS INJURY
UNK
GENERAL AND PLASTIC SURGERY
FTR
FINAL
PT HAD INFLAMMATION IN HER JOINTS. NO DEVICE RETURNED, NO CONCLUSION CAN BE DRAWN.
THESE DEVICES ARE NO LONGER COMMERCIALLY AVAILABLE AND CAN ONLY BE USED UNDER CONTROLLED CLINICAL TRIALS. THESE TYPES OF EVENTS USUALLY INVOLVE KNOWN COMPLICATIONS WHICH DO NOT JUSTIFY IMMEDIATE ACTION OR REVIEW OF THE INDIVIUAL REPORT. HOWEVER, THE EVENT AND OTHER SIMILAR EVENTS ARE AVAILABLE FOR FURTHER STATISTICAL ANALYSIS AND MONITORING.
M765761
1997-01-22
SILASTIC (R) II MAMMARY IMPLANT, H.P. LPR
DOWCORN
DOW CORNING CORP.
2200 WEST SALZBURG ROAD
AUBURN
MI
48611
SERIOUS INJURY
P1040320
GENERAL AND PLASTIC SURGERY
FTR
FINAL
MAMMOGRAM OF 5/29/92 SHOWS NO SUSPICIOUS MASSES; HOWEVER, CLUSTERS OF CALCIFICATIONS OR ABNORMAL VASCULARITY WERE SEEN. PT HAD REMOVAL OF IMPLANTS WITH CAPSULECTOMY AND OPERATIVE REPORT SHOWS ABOUT ONE HOUR AFTER EXPLANTATION, PT DEVELOPED A HEMATOMA ON THE LEFT SIDE IN THE UPPER/OUTER PART OF THE BREAST POCKET TOWARDS THE AXILLA. THE BLEEDING WAS ENCOUNTERED AND SEVERAL SMALL AREAS WERE CAUTERIZED WHICH STOPPED THE ACTIVE BLEEDING. THE DEVICE WERE RETURNED TO CO AND UPON VISUAL EXAM THEY WERE BOTH FOUND TO BE INTACT. THE DEVICES WERE THEN RETURNED TO THE PT ON 7/16/96 WITHOUT FURTHER EVALUATION.
THESE DEVICES ARE NO LONGER COMMERCIALLY AVAILABLE AND CAN ONLY BE USED UNDER CONTROLLED CLINICAL TRIALS. THESE TYPES OF EVENTS USUALLY INVOLVE KNOWN COMPLICATIONS WHICH DO NOT JUSTIFY IMMEDIATE ACTION OR REVIEW OF THE INDIVIUAL REPORT. HOWEVER, THE EVENT AND OTHER SIMILAR EVENTS ARE AVAILABLE FOR FURTHER STATISTICAL ANALYSIS AND MONITORING.
Demos
