D
Patient 1
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE OF HIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO AIR IN SYSTEM 2 YEARS AFTER IMPLANT. DEVICE WAS RE-PREPPED AND REFILLED. NO COMPONENTS WERE EXPLANTED.
MAUDE MDR 9908238
- MDR report key
- 9908238
- Report number
- 2183959-2020-01779
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-06
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ALYSON HARRIS
- Address
- 10700 BREN ROAD W MINNETONKA MN 55343 US
- Phone
- 408-408-4089
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AMS INFLATABLE PENILE PROSTHESIS | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC | BOSTON SCIENTIFIC CORPORATION | FHW | UNK-P-IPP | UNK-P-IPP | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H; 2. R |