FDA Adverse Event
Malfunction
Summary report: N
STORZ KELLY DECEMET MEMBRANE PUNCH
MDR report key: 73390
·
Received January 3, 1997
Report
- Report Number
- 1932180-1997-00001
- Event Type
- Malfunction
- Date Received
- January 3, 1997
- Date of Event
- August 22, 1996
- Report Date
- December 3, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HNJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING AN OPHTHALMIC PROCEDURE, PIECES OF THE COATING OF THIS INSTRUMENT FELL OFF INTO THE EYE. THE PIECES WERE ABLE TO BE ASPIRATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ KELLY DECEMET MEMBRANE PUNCH | OPHTHALMIC MEMBRANE PUNCH | HNJ | STORZ INSTRUMENT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |