D
Patient 1
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.
MAUDE MDR 188065
- MDR report key
- 188065
- Report number
- 1932180-1998-00056
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-08-18
- Date received
- 1998-09-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL TREPHINE HANDLE WITH COTTINGHAM PUNCH | TREPHINE PUNCH | BAUSCH & LOMB SURGICAL | HRH | NA | E3097 | NA | N | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1998-09-16 | 0 |