MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for ST JUDE PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F 408296 manufactured by St Jude / Abbott Laboratories.
[116047726]
Endomyocardial biopsy forceps did not open properly during biopsy procedure, requiring a new forceps to be used. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078789 |
| MDR Report Key | 7742740 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-06-13 |
| Date Added to Maude | 2018-08-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ST JUDE PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS 7F |
| Generic Name | FORCEPS / BIOPSY |
| Product Code | KGE |
| Date Received | 2018-08-01 |
| Model Number | 408296 |
| Catalog Number | 408296 |
| Lot Number | 9915399 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE / ABBOTT LABORATORIES |
| Manufacturer Address | PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-01 |