FDA Adverse Event
Injury
Summary report: N
AMS 700 INFLATABLE PENILE PROSTHESIS
MDR report key: 1923598
·
Received December 10, 2010
Report
- Report Number
- 2183959-2010-00450
- Event Type
- Injury
- Date Received
- December 10, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 12, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FHW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): CYLINDER PERFORMED WITHIN SPECIFICATION. PUMP PERFORMED WITHIN SPECIFICATION. RESERVOIR PERFORMED WITHIN SPECIFICATION. THE DEVICE WAS RETURNED AND ANALYZED, RATED IN SPECIFICATION. THE ANALYSIS RESULTS DID NOT ESTABLISH A RELATIONSHIP TO A DEVICE MALFUNCTION. THIS IS CONSIDERED AN UNUSUAL EVENT IN WHICH AN AMS INFLATABLE PENILE PROSTHESIS WAS INVOLVED.
Description of Event or Problem · 1
ON (B)(6) 2004, PT HAD AN IPP DEVICE IMPLANTED. INFO RECEIVED ON (B)(6) 2010, INDICATES THE DEVICE IS NOT PROPERLY FUNCTIONING. ON (B)(6) 2010, THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE PT DISSATISFACTION. AFTER EXPLORATION, IT WAS FOUND THAT "ONE OF THE CYLINDERS WAS OUTSIDE THE CORPORAL BODY AND PROTRUDING INTO THE SCROTUM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS 700 INFLATABLE PENILE PROSTHESIS | IPP | FHW | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R |