FDA Adverse Event
Injury
Summary report: N
AMS 700 INFLATABLE PENILE PROSTHESIS
MDR report key: 2212461
·
Received August 11, 2011
Report
- Report Number
- 2183959-2011-00292
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- February 24, 2009
- Report Date
- February 24, 2009
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE REEVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 2008, AN IPP WAS IMPLANTED. ON (B)(6) 2009, A REVISION SURGERY OCCURRED. IT WAS INDICATED THAT AN ACCESSORY KIT WAS USED AT THIS PROCEDURE. IT IS UNKNOWN WHAT OCCURRED, ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS 700 INFLATABLE PENILE PROSTHESIS | IPP | FAE | AMERICAN MEDICAL SYSTEMS, INC. | 700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |