D
Patient 1
IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE IS GOING TO BE REVISED BECAUSE THEY HAVE BEEN UNABLE TO ACTIVATE THE PUMP SINCE THE DEVICE WAS ORIGINALLY IMPLANTED.
MAUDE MDR 9908131
- MDR report key
- 9908131
- Report number
- 2183959-2020-01760
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-14
- 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 WITH INHIBIZONE | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC | BOSTON SCIENTIFIC CORPORATION | FHW | 72404255 | 72404255 | 1000177195 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |