FDA Adverse Event
Malfunction
Summary report: N
INFLATABLE PENILE PROSTHESIS
MDR report key: 1600797
·
Received February 3, 2010
Report
- Report Number
- 2183959-2010-00043
- Event Type
- Malfunction
- Date Received
- February 3, 2010
- Date of Event
- December 10, 2009
- Report Date
- February 3, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- JCW
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A (B)(6) OLD SEVERELY DIABETIC MALE WAS IMPLANTED WITH AN IPP DEVICE (B)(6) 2007. ON (B)(6) 2009 PATIENT REPORTED THAT HIS DOCTOR TOLD HIM THAT HIS 700 PUMP NEEDS TO BE REPLACED AS THE DOCTOR THOUGHT THERE MIGHT BE A KINK/TWIST IN THE TUBING PREVENTING FLUID FROM FLOWING. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFLATABLE PENILE PROSTHESIS | IPP | JCW | AMERICAN MEDICAL SYSTEMS, INC. | IPP | 486790002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Disability |