FDA Adverse Event
Injury
Summary report: N
AMS INFLATABLE PENILE PROSTHESIS
MDR report key: 3445579
·
Received October 31, 2013
Report
- Report Number
- 2183959-2013-01141
- Event Type
- Injury
- Date Received
- October 31, 2013
- Date of Event
- August 15, 2011
- Report Date
- September 14, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESERVOIR, CATALOG#: 7240415, SERIAL #: (B)(4), EXPIRATION DATE: 08/25/2012, MANUFACTURE DATE: 08/2010. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Additional Manufacturer Narrative · 1
RESERVOIR, CATALOG#: 7240415, SERIAL #: (B)(4), EXPIRATION DATE: 08/25/2012, MANUFACTURE DATE: 08/2010. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD HIS INFLATABLE PENILE PROSTHESIS REPLACED DUE TO "FAILURE OF DEVICE", INFECTION, AND ERODED TUBING. NO ADDITIONAL PT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 558707 | AMS INFLATABLE PENILE PROSTHESIS | PENILE PROSTHESIS | FAE | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| O| R| S |