MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-16 for UNIVERSAL TREPHINE HANDLE WITH COTTINGHAM PUNCH E3097 manufactured by Bausch & Lomb Surgical.
[21388442]
The donor cornea button was ruined when the trephine blade shipped in this punch. The pt's cornea has been removed prior to preparation of the donor cornea. The pt returned for a successful cornal transplant the week of 9/7/98.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1998-00056 |
| MDR Report Key | 188065 |
| Report Source | 05,06 |
| Date Received | 1998-09-16 |
| Date of Report | 1998-08-18 |
| Date of Event | 1998-08-18 |
| Date Facility Aware | 1998-08-18 |
| Report Date | 1998-08-18 |
| Date Reported to Mfgr | 1998-08-18 |
| Date Mfgr Received | 1998-08-18 |
| Date Added to Maude | 1998-09-22 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL TREPHINE HANDLE WITH COTTINGHAM PUNCH |
| Generic Name | TREPHINE PUNCH |
| Product Code | HRH |
| Date Received | 1998-09-16 |
| Model Number | NA |
| Catalog Number | E3097 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182775 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 499 SOVEREIGN CT. ST LOUIS MO 63011 US |
| Baseline Brand Name | UNIVERSAL TREPHINE HANDLE WITH COTTINGHAM PUNCH |
| Baseline Generic Name | TREPHINE, MANUAL OPHTHALMIC |
| Baseline Model No | NA |
| Baseline Catalog No | E3097 |
| Baseline ID | NA |
| Baseline Device Family | OPHTHALMIC MANUAL TREPHINE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-09-16 |