MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-25 for STORZ 4C * manufactured by Bausch & Lomb Surgical.
[167826]
Pt underwent a right tympano-mastoidectomy. During procedure tip of micro ear curette instrument broke off (2mm). The ear was examined & irrigated under microscopy & no foreign body noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 292306 |
| MDR Report Key | 292306 |
| Date Received | 2000-08-25 |
| Date of Report | 2000-08-24 |
| Date of Event | 2000-08-23 |
| Date Facility Aware | 2000-08-23 |
| Report Date | 2000-08-24 |
| Date Added to Maude | 2000-08-29 |
| 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 | STORZ |
| Generic Name | MICRO EAR CURETTE |
| Product Code | JYG |
| Date Received | 2000-08-25 |
| Model Number | 4C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SIZE J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 282921 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 555 WEST ARROW HWY CLAIREMONT CA 91711 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-25 |