FDA Adverse Event
Injury
Summary report: N
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
MDR report key: 7982343
·
Received October 18, 2018
Report
- Report Number
- 2183959-2018-60288
- Event Type
- Injury
- Date Received
- October 18, 2018
- Date of Event
- September 18, 2018
- Report Date
- October 18, 2018
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FHW
- UDI-DI
- 00878953003597
- PMA / PMN Number
- N970012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SAME CASE AS REPORT NUMBER: 2183959-2018-60288. IT WAS REPORTED THAT THE PATIENT HAD AN ARTIFICIAL URINARY SPHINCTER (AUS) AND INFLATABLE PENILE PROSTHESIS (IPP) REVISED DUE TO THE AUS PUMP AND IPP PUMP ENCAPSULATE TOGETHER CAUSING THE AUS PUMP TO BE DIFFICULT TO SQUEEZE. NO DEVICE WAS EXPLANTED THE AUS PUP WAS MOVED MORE LATERALLY IN THE SCROTUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822991 | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC | FHW | BOSTON SCIENTIFIC CORPORATION | 72404251 | 1000075115 | 00878953003597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |