MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-18 for HOUSE STAPES CURETTE, 6" DOUBLE-ENDED, 2MMX2.5MM * 385-402 manufactured by Hebu Medical Gmbh.
[21581373]
The cupped end of the curette broke off in the pt's ear. The broken piece was retrieved. No harm was reported to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2004-00031 |
| MDR Report Key | 555792 |
| Date Received | 2004-11-18 |
| Date of Report | 2004-11-18 |
| Report Date | 2004-11-18 |
| Date Added to Maude | 2004-11-22 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | HOUSE STAPES CURETTE, 6" DOUBLE-ENDED, 2MMX2.5MM |
| Generic Name | EAR/NOSE INSTRUMENT |
| Product Code | JYG |
| Date Received | 2004-11-18 |
| Model Number | * |
| Catalog Number | 385-402 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 545438 |
| Manufacturer | HEBU MEDICAL GMBH |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-18 |