MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-23 for STAPES CURETTE N1705 K manufactured by Bausch & Lomb.
[285681]
During the course of middle ear surgery, the tip of the stainless steel curette broke off. The remaining shaft of curette slipped and injured the pt, resulting in temporary facial paralysis. The pt has recovered with no further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 437665 |
| MDR Report Key | 437665 |
| Date Received | 2002-12-23 |
| Date of Report | 2002-11-27 |
| Date of Event | 2002-06-07 |
| Date Facility Aware | 2002-06-07 |
| Report Date | 2002-06-10 |
| Date Reported to Mfgr | 2002-11-27 |
| Date Added to Maude | 2003-01-16 |
| 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 | STAPES CURETTE |
| Generic Name | MIDDLE EAR INSTRUMENTS |
| Product Code | JYG |
| Date Received | 2002-12-23 |
| Model Number | NA |
| Catalog Number | N1705 K |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 426606 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 3365 TREECOURT INDUSTRIAL BLVD ST. LOUIS MO 63122 US |
| Baseline Brand Name | STAPES CURETTE |
| Baseline Generic Name | MIDDLE EAR INSTRUMENTS |
| Baseline Model No | NA |
| Baseline Catalog No | N1705 K |
| Baseline ID | NA |
| Baseline Device Family | ENT INSTRUMENTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-12-23 |