FDA Adverse Event
Injury
Summary report: N
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
MDR report key: 8047982
·
Received November 7, 2018
Report
- Report Number
- 2183959-2018-60786
- Event Type
- Injury
- Date Received
- November 7, 2018
- Date of Event
- October 10, 2018
- Report Date
- November 7, 2018
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FHW
- UDI-DI
- 00878953005669
- PMA / PMN Number
- N970012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER: 7240453; SERIAL NUMBER: NULL. BATCH/LOT NUMBER: 156060001. MODEL/CATALOG DESCRIPTION: LGX PRECONNECT MS 12CM PS IZ.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE DEVICE NOT INFLATING DUE TO A HOLE IN THE RESERVOIR IN THE TUBING HUB WITH A INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER, PUMP AND RESERVOIR WERE EXPLANTED AND A 21 CM LGX IPP SYSTEM WAS IMPLANTED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889287 | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE | DEVICE IMPOTENCE MECHANICAL/HYDRAULIC | FHW | BOSTON SCIENTIFIC CORPORATION | 720185-01 | 0182471018 | 00878953005669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |