MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-12 for CRAWFORD FASCIA STRIPPER N4298 * manufactured by Bausch & Lomb, Inc..
[1090519]
Surgeon used fascia stripper to obtain fascia to be used in a blepharoptosis repair. It was very hard to use and another procedure had to be performed to obtain the fascia. When the instrument was taken to the processing room to be cleaned, it was noted that a screw was missing. The patient's leg was x-rayed and showed a retained screw. The screw was surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1406965 |
| MDR Report Key | 1406965 |
| Date Received | 2009-06-12 |
| Date of Report | 2009-05-11 |
| Date of Event | 2008-10-23 |
| Report Date | 2009-05-11 |
| Date Reported to FDA | 2009-06-12 |
| Date Added to Maude | 2009-06-26 |
| 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 |
| 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 | CRAWFORD FASCIA STRIPPER |
| Generic Name | INSTRUMENT, OPHTHALMIC PLASTIC |
| Product Code | HRT |
| Date Received | 2009-06-12 |
| Model Number | N4298 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 21 PARK PLACE BOULEVARD CLEARWATER FL 33759 US 33759 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-12 |