MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-07-10 for TANNE DISPOSABLE TREPHINE BLADE E3050 8.25 manufactured by Bausch & Lomb Surgical.
[15745813]
When the donor cornea was cut using this blade, the edges of the cornea looked ragged. When the donor cornea was placed onto the pt's eye, the ragged edges were actually pieces of metal. The physician was able to remove as much particulate as was possible. The pt is not suffering any adverse effects as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1998-00040 |
| MDR Report Key | 176413 |
| Report Source | 05,06 |
| Date Received | 1998-07-10 |
| Date of Report | 1998-06-09 |
| Date of Event | 1998-06-09 |
| Date Facility Aware | 1998-06-09 |
| Report Date | 1998-06-09 |
| Date Reported to Mfgr | 1998-06-09 |
| Date Mfgr Received | 1998-06-09 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-07-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANNE DISPOSABLE TREPHINE BLADE |
| Generic Name | TREPHINE BLADE |
| Product Code | HRH |
| Date Received | 1998-07-10 |
| Model Number | NA |
| Catalog Number | E3050 8.25 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 171508 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 499 SOVEREIGN CT. ST. LOUIS MO 63011 US |
| Baseline Brand Name | TANNE DISPOSABLE TREPHINE BLADE |
| Baseline Generic Name | TANNE DISPOSABLE TREPHINE BLADE |
| Baseline Model No | * |
| Baseline Catalog No | E3050 8.25 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-10 |