FDA Adverse Event
Injury
Summary report: N
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
MDR report key: 17595394
·
Received August 22, 2023
Report
- Report Number
- 2124215-2023-44993
- Event Type
- Injury
- Date Received
- August 22, 2023
- Date of Event
- August 3, 2023
- Report Date
- August 22, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EZY
- UDI-DI
- 00878953003078
- PMA / PMN Number
- P000053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED DIFFICULTY TO ACCESS TO THE PUMP, DUE TO A MALPOSITION OF THE COMPONENT. THE PUMP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301667 | AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC | EZY | BOSTON SCIENTIFIC CORPORATION | 72404127 | 1100268795 | 00878953003078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Unknown | Hospitalization| R | BALLOON: UPN: 72400024 / LOT: 1100285780| CUFF: UPN: 72404131 / LOT: 1100272243 |