MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for AMS 800 URINARY CONTROL SYSTEM 72400160 manufactured by Boston Scientific Corporation.
[188192251]
It was reported that the patient underwent an artificial urinary sphincter (aus) replacement surgery due to unspecified reasons. During the procedure the existing device was removed and a new aus was implanted. No information was provided about the patient's outcome. It was further reported that the patient experienced recurring incontinence leading to the procedure. During the surgery urethral atrophy was noted at the cuff site. There were no device malfunctions associated with the explanted aus. The patient did not experience any further adverse events and was said to be good following the procedure. No more information available at the moment. Should additional information become available, it will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01669 |
| MDR Report Key | 9891882 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2007-03-30 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALYSON HARRIS |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 4083953452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 800 URINARY CONTROL SYSTEM |
| Generic Name | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC |
| Product Code | EZY |
| Date Received | 2020-03-27 |
| Model Number | 72400160 |
| Catalog Number | 72400160 |
| Lot Number | 486679020 |
| Device Expiration Date | 2012-03-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |