D
Patient 1
THIS SPECULUM BROKE DURING AN OPHTHALMIC PROCEDURE WHILE IN THE PT'S EYE. ANOTHER SPECULUM WAS USED. THERE WAS NO PT INJURY.
MAUDE MDR 165381
- MDR report key
- 165381
- Report number
- 1932180-1998-00024
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-04-01
- Date received
- 1998-04-27
- 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 | STORZ BARRAQUER EYE SPECULUM | OPHTHALMIC SPECULUM | STORZ INSTRUMENT COMPANY | HNC | NA | E4106 S | NA | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1998-04-27 | 0 |