AMS 800 URINARY CONTROL SYSTEM Adverse Event — Injury (MDR 2183959-2020-02120)
AMS 800 URINARY CONTROL SYSTEM Adverse Event — Injury (MDR 2183959-2020-02120) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AMS 800 URINARY CONTROL SYSTEM; Generic name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | AMS 800 URINARY CONTROL SYSTEM |
|---|---|
| Generic name | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2183959-2020-02120 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING A REVISION PROCEDURE DUE TO RECURRING INCONTINENCE THAT BEGAN (B)(6) 2020 WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS REMAINS IMPLANTED AND ACTIVE. |
| Source | openFDA MAUDE (device adverse events) |
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