MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-04 for FLEXIBLE BIOPSY FORCEPS-ELONGTED CUP manufactured by Cook.
[9574]
In cardiac cath lab undergoing multiple biopsies of the myocardium. Suddenly became hypotensive and developed cardiac tamponade. Pericardiocentesis done to evacuate effusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10176 |
| MDR Report Key | 10176 |
| Date Received | 1993-09-04 |
| Date of Report | 1993-09-02 |
| Date of Event | 1993-08-23 |
| Date Facility Aware | 1993-08-23 |
| Date Reported to FDA | 1993-09-02 |
| Date Reported to Mfgr | 1993-09-02 |
| Date Added to Maude | 1993-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE BIOPSY FORCEPS-ELONGTED CUP |
| Generic Name | BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 1993-09-04 |
| Lot Number | 424153 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10176 |
| Manufacturer | COOK |
| Manufacturer Address | PO BOX 489 BLOOMINGTON IN 47402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-09-04 |