FDA Adverse Event
Other
Summary report: N
FUNDUS FCPS DA 5MM INLINE
MDR report key: 490046
·
Received October 15, 2003
Report
- Report Number
- 8010877-2003-00003
- Event Type
- Other
- Date Received
- October 15, 2003
- Report Date
- September 8, 2003
- Manufacturer
- KOSCHER & WURTZ GMBH
- Product Code
- HCZ
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT ON BOTH INSTRUMENTS THE HINGE BROKE DURING USE. THERE WAS NO PATIENT INJURY WHATSOEVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUNDUS FCPS DA 5MM INLINE | * | HCZ | KOSCHER & WURTZ GMBH | * | 0300084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |