Demos
Others titles
- MedSun Adverse Events Reports
- MD Medical Product Safety Network
- Medical Devices Safety Network
Keywords
- Medical Product Safety
- Adverse Event Reporting Program
- MedSun
- MD Safety
- MD Reporting
Medical Product Safety Network
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
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Description
The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.
The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.
About this Dataset
Data Info
| Date Created | 2002 |
|---|---|
| Last Modified | 2024-06-13 |
| Version | 2024-06-13 |
| Update Frequency |
Daily |
| Temporal Coverage |
2006-03-24 to 2024-06-13 |
| 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 | Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting |
| Other Titles | MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network |
Data Fields
| Name | Description | Type | Constraints |
|---|---|---|---|
| Device_Brand | The brand of medical device | string | - |
| Device_Manufacturer | Device manufacturer name | string | - |
| Device_Type | The type of medical device | string | - |
| Device_Problem | Problem associated with the device | string | - |
| Date_Report | The Date report | date | required : 1 |
| Event_Description | The Event description | string | - |
Data Preview
| Device Brand | Device Manufacturer | Device Type | Device Problem | Date Report | Event Description |
| KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK USA INC. | CEMENT BONE VERTEBROPLASTY | Death | 2024-12-04 | According the medical record - the patient was undergoing spinal surgery - posterior spinal fusion thoracic T10 through lumbar L2 with treatment of pathologic fracture thoracic T12. During surgery - the surgeon injected bone cement into the fenestrated screws under fluoroscopic imaging to observe the filling. At thoracic T10 level the surgeon noted that the cement was minimized due to the observation of some cement extravasation at that level. No other issues were observed while filling at T11 - L1 or L2 levels. Surgery continued and the surgeon was informed that there was a pulmonary event with concern for pulmonary embolism. Surgeon noted due to timing of event - concern for cement monomer embolization leading to reaction. Patient quickly flipped - cardiopulmonary resuscitation initiated - Code Blue - patient expired. |
| EndoWrist | INTUITIVE SURGICAL INC. | System surgical computer controlled instrument | Not known | 2024-12-04 | One of the wires broke on a force bipolar |
| CVAC Aspiration System | Calyxo Inc. | Ureteroscope And Accessories Flexible/Rigid | Death | 2024-12-04 | The single use Calyxo 2nd Generation CVAC2 ureteroscope is a new ureteroscope that is designed to suction stone particles and fluid out through the scope itself. This is different than standard ureteroscopes which rely on passive drainage of fluid around the ureteroscope. As a result of the internal suction mechanism - the CVAC ureteroscope is thicker than the standard ureteroscope and therefore cannot rely as much on passive drainage around the ureteroscope. For this reason - in part - the manufacturerâs guidance for use of this ureteroscope suggests using a large (12/14 french) access sheath to help with passive drainage. What Happened: The patient came in for an elective same day procedure on (retrated date and time). The above type of 2nd Generation CVAC2 Calyxo ureteroscope was used and the procedure continued as expected - with the breaking up of stone. The12/14 Fr access sheath was used as described in the manufacturer suggested practice to help drain around the ureteroscope in addition to the scopeâs internal drainage. A Calyxo device representative was present for the entire duration of the surgery. After the conclusion of the procedure - the patient was seen to be hypotensive with hematuria resulting in blood work - which suggested stable hemoglobin raising concern for urosepsis and transfer to ICU at (retracted time). In the ICU - the patient was not responding as expected to pressor agents and hematuria continued. Repeat blood work showed a significant drop in blood counts. Blood work also suggested the patient to be experiencing disseminated intravascular coagulation (DIC) (a serious condition that causes abnormal blood clotting throughout the body). This resulted in aggressive blood transfusion resuscitation and return to the operating room where renal embolization was attempted by Interventional Radiology. Because of concern for abdominal compartment syndrome (a medical emergency that occurs when the pressure in the abdomen rises to dangerous levels - causing organ dysfunction) - exploratory laparotomy (large incision in abdominal wall) was performed - during which what looked like a pressure induced traumatic injury of the right kidney was seen associated with ongoing bleeding resulting in nephrectomy. While surgery was ongoing the patient developed cardiovascular arrest and ultimately the patient expired in the OR at (retracted time). In retrospect - a similar experience resulting from a use of the 2nd generation Calyxo ureteroscopes - in which suspected greater than normal internal pressure resulted in extravasation of contrast on retrograde at the end of the procedure and post operative acute blood loss anemia resulting in multiple day hospital stay for close observation. We have experienced three episodes of renal bleeding associated with cystoscopy using this 2nd generation device. We suspect that the bleeding episodes were the result of an increase in in renal pressure - likely due to how the scope allows for drainage and enables suction. We suspect that the lack of sufficient drainage and/or appropriate suction leads to increased intra-renal pressure - resulting in potential trauma/bleeding for patients. In all three cases the recommendation for and use of the 12/14 french access sheath was followed. St. Lukeâs has removed all stock of this device and found them to all be from the same lot. St. Lukeâs discontinued use of this ureteroscope. |
| ANGIO-SEAL | TERUMO MEDICAL CORPORATION | Device hemostasis vascular | Minor injury to the patient or health care provider | 2024-12-04 | Successful splenic artery embolization with particles and coils. Left groin closed with Angio-Seal Vascular Closure Device. Pseudoaneurysm following Angio-Seal closure. Patient required surgical repair of pseudoaneurysm. |
| VCARE | Conmed Corporation | Cannula manipulator/injector uterine | Potential for patient harm | 2024-12-03 | CONMED VCare Plus broke during surgery - manipulator handle malfunctioned - no longer holding tension. |
| Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES INC. | Ventilator Emergency Powered (Resuscitator) | Potential for patient harm | 2024-12-03 | T-piece for newborn resuscitation misfunctioned. Unable to set pip/peep on device. |
| CARDINAL HEALTH | CARDINAL HEALTH 200 LLC | Infant heel warmer (chemical heat pack) | Potential for patient harm | 2024-12-03 | Infant heel warmers noted to have been activated and are arriving defective and unusable - forty five (45) breaches last week. |
| Optilite | Convergent Laser Technologies | Powered Laser Surgical Instrument | Potential for patient harm | 2024-12-03 | Fiber did not operate at surgical site - no smoke present - no spark present - no flame present. The fiber appeared not to be intact within the laser fiber sheath when initially turned on during use - light visualized in the fiber sheath - laser operator discontinued use - disconnected from laser and replaced - weak aiming beam. |
| Instinct | COOK INCORPORATED | Hemostatic metal clip for the GI tract | Potential for patient harm | 2024-12-03 | Attempted to deploy Cook clip during colonoscopy - but would not open or deploy. |
| EndoFLIP | Covidien LP | SYSTEM GASTROINTESTINAL MOTILITY (ELECTRICAL) | Potential for patient harm | 2024-12-03 | Catheter passed test prior to use - during procedure when inserted into the esophagus and inflated - balloon inflated but would not register pressure. After several attempts - another catheter was opened and set up. The newly opened catheter functioned appropriately. |