FDA Adverse Event
Other
Summary report: N
MALLEABLE PENILE IMPLANT
MDR report key: 29736
·
Received December 23, 1995
Report
- Report Number
- 29736
- Event Type
- Other
- Date Received
- December 23, 1995
- Report Date
- March 10, 1995
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAE
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT DISSATISFIED; REQUESTED A DIFFERENT MODEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLEABLE PENILE IMPLANT Implant | MALLEABLE PENILE IMPLANT | FAE | AMERICAN MEDICAL SYSTEMS, INC. | MALLEABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |