FDA Adverse Event
Injury
Summary report: N
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
MDR report key: 10613027
·
Received October 1, 2020
Report
- Report Number
- 2183959-2020-04404
- Event Type
- Injury
- Date Received
- October 1, 2020
- Date of Event
- September 10, 2020
- Report Date
- October 1, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FHW
- UDI-DI
- 00878953003641
- PMA / PMN Number
- N970012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RELATED COMPONENT: 72404155, 593372002, RESERVOIR 65 ML PC/IZ.
Description of Event or Problem · 1
IT WAS REPORTED THAT INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER ERODED LATERALLY, THE PUMP MIGRATED TROUGH THE CARTON LAYERS AND WAS SKIN VISIBLE. PATIENT EXPERIENCED PAIN. ALL COMPONENTS WERE EXPLANTED AND NO NEW DEVICE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1078173 | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC | FHW | BOSTON SCIENTIFIC CORPORATION | 72404256 | 581232002 | 00878953003641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |