FDA Adverse Event
Injury
Summary report: N
INFLATABLE PENILE PROSTHESIS
MDR report key: 2111774
·
Received May 25, 2011
Report
- Report Number
- 2183959-2011-00181
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 30, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED FOR ANALYSIS. THE PUMP PERFORMED ACCORDING TO SPECS.
Description of Event or Problem · 1
ON (B)(6) 2009, AN IPP WAS IMPLANTED. ON (B)(6) 2011, THE PUMP COMPONENT WAS REMOVED AND REPLACED DUE TO "AUTO INFLATION." NO PT COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFLATABLE PENILE PROSTHESIS | IPP | FAE | AMERICAN MEDICAL SYSTEMS, INC. | 700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |