MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-14 for FLETCHER- VAN DOREN UTERINE POLYP FORCEP * GL1805 manufactured by Allegiance.
[97264]
At the end of the procedure, a piece of the jaw of the uterine polyp forcep was noted to be missing. Search of area and specimen, tissue and pelvic exam did not reveal broken part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 167924 |
| MDR Report Key | 167924 |
| Date Received | 1998-05-14 |
| Date of Report | 1998-05-12 |
| Date of Event | 1998-05-11 |
| Date Facility Aware | 1998-05-11 |
| Report Date | 1998-05-12 |
| Date Reported to Mfgr | 1998-05-12 |
| Date Added to Maude | 1998-05-20 |
| 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 | FLETCHER- VAN DOREN UTERINE POLYP FORCEP |
| Generic Name | UTERINE POLYP FORCEP |
| Product Code | HCZ |
| Date Received | 1998-05-14 |
| Returned To Mfg | 1998-05-12 |
| Model Number | * |
| Catalog Number | GL1805 |
| Lot Number | XRBN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 DAY |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 163393 |
| Manufacturer | ALLEGIANCE |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-14 |