FDA Adverse Event
Injury
Summary report: N
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
MDR report key: 10162320
·
Received June 17, 2020
Report
- Report Number
- 2183959-2020-02564
- Event Type
- Injury
- Date Received
- June 17, 2020
- Date of Event
- May 27, 2020
- Report Date
- June 18, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FHW
- UDI-DI
- 00878953003504
- PMA / PMN Number
- N970012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
FIELD CHANGE: G.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF HIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO DISCOMFORT. DEVICE HAS SUSPECTED TO HAVE FLUID LOSS. ALL COMPONENTS WERE EXPLANTED AND REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF HIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO DISCOMFORT. DEVICE HAS SUSPECTED TO HAVE FLUID LOSS. ALL COMPONENTS WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625649 | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC | FHW | BOSTON SCIENTIFIC CORPORATION | 72404237 | 843484002 | 00878953003504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| R |