MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-06-24 for TANNE DISPOSABLE TREPHINE BLADE E3050 8.25 manufactured by Bausch & Lomb Surgical.
[20193226]
This trephine blade shattered when used on the donor cornea. Pieces of the blade were transferred to the pt via the donor cornea. The physician attempted to remove all the particulate at the time of the procedure. There has been no report of pt injury to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1998-00038 |
| MDR Report Key | 175006 |
| Report Source | 05,06 |
| Date Received | 1998-06-24 |
| Date of Report | 1998-06-01 |
| Date of Event | 1998-06-01 |
| Date Facility Aware | 1998-06-01 |
| Report Date | 1998-06-01 |
| Date Reported to Mfgr | 1998-06-01 |
| Date Mfgr Received | 1998-06-01 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-07-02 |
| 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 | 1998-06-24 |
| Model Number | NA |
| Catalog Number | E3050 8.25 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 170159 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 499 SOVEREIGN COURT 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 | 1998-06-24 |