MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-07-13 for CRAWFORD FASCIA STRIPPER N4298 manufactured by Bausch & Lomb.
[1098659]
Event desc: 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 pt's leg was x-rayed and showed a retained screw. The screw was surgically removed. Did this event involve an electrophysiology procedure or an attempted electrophysiology procedure? No. What was the original intended procedure? Harvesting of fascia. Device usage problem: device failed (e. G. Broke, couldn't get it to work".
Patient Sequence No: 1, Text Type: D, B5
[8293736]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2009-00159 |
| MDR Report Key | 1430783 |
| Report Source | 06 |
| Date Received | 2009-07-13 |
| Date of Report | 2009-05-11 |
| Date of Event | 2008-10-23 |
| Report Date | 2009-05-01 |
| Date Reported to FDA | 2009-06-01 |
| Date Mfgr Received | 2009-06-29 |
| Date Added to Maude | 2009-08-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANET LACAVICH |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263213 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRAWFORD FASCIA STRIPPER |
| Generic Name | INSTRUMENT, OPHTHALMIC PLASTIC |
| Product Code | HRT |
| Date Received | 2009-07-13 |
| Model Number | N4298 |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-13 |