FDA Adverse Event
Other
Summary report: N
AMERICAN MEDICAL SYSTEMS
MDR report key: 501901
·
Received November 21, 2003
Report
- Report Number
- MW1030410
- Event Type
- Other
- Date Received
- November 21, 2003
- Date of Event
- October 23, 2003
- Report Date
- November 18, 2003
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- FHW
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FAILED IMPLANT PER MD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMERICAN MEDICAL SYSTEMS | PENILE IMPLANT | FHW | AMERICAN MEDICAL SYSTEMS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |