D
Patient 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN SPECTRA PENILE PROSTHESIS(IPP) DEVICE DUE TO UNSPECIFIED REASONS. A PATIENT OUTCOME WAS NOT REPORTED.
MAUDE MDR 9694074
- MDR report key
- 9694074
- Report number
- 2183959-2020-00595
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-17
- Date received
- 2020-02-11
- 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 SPECTRA CONCEALABLE PENILE PROSTHESIS | PROSTHESIS PENILE | BOSTON SCIENTIFIC CORPORATION | FAE | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-11 | 0 | 1. H; 2. O |