MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-30 for STAPES CURRETTE * manufactured by Cardinal V Mueller, Cardinal Health Corp..
[524350]
Surgeon using a stapes currette to scrape mastoid bone and the top of the ear canal, and the instrument broke at the neck. Piece that broke off was very visible under enlarged view of microscope, and the entire piece was removed. No adverse effect for pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036494 |
| MDR Report Key | 747300 |
| Date Received | 2005-08-30 |
| Date of Report | 2005-08-30 |
| Date of Event | 2005-08-23 |
| Date Added to Maude | 2006-08-15 |
| 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 | RISK MANAGER |
| 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 | STAPES CURRETTE |
| Generic Name | CURRETTE |
| Product Code | KAP |
| Date Received | 2005-08-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | ZFFC03 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 735075 |
| Manufacturer | CARDINAL V MUELLER, CARDINAL HEALTH CORP. |
| Manufacturer Address | 1210 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-30 |