FDA Adverse Event
Other
Summary report: N
AMERICAN MEDICAL SYSTEMS
MDR report key: 121956
·
Received September 22, 1997
Report
- Report Number
- 121956
- Event Type
- Other
- Date Received
- September 22, 1997
- Date of Event
- August 29, 1997
- Report Date
- September 15, 1997
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- FHW
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
MFG IMPLANTABLE PENILE PROSTHESIS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMERICAN MEDICAL SYSTEMS Implant | IMPLANTABLE PENILE PROSTHESIS 700 | FHW | AMERICAN MEDICAL SYSTEMS | IPP700 PUMP/65ML | 4057C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | NONE KNOWN. |