FDA Adverse Event
Injury
Summary report: N
APHI
MDR report key: 293342
·
Received August 30, 2000
Report
- Report Number
- 2125050-2000-00009
- Event Type
- Injury
- Date Received
- August 30, 2000
- Date of Event
- July 11, 2000
- Report Date
- August 30, 2000
- Manufacturer
- MENTOR CORPORATION - MINNESOTA DIVISION
- Product Code
- FWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FAILED PENILE PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APHI | INFLATABLE PENILE PROSTHESIS | FWN | MENTOR CORPORATION - MINNESOTA DIVISION | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R |