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 WITH INHIBIZONE 720157-01 manufactured by Boston Scientific Corporation.
[186296681]
It was reported that the patient experienced erosion and infection with an artificial urinary sphincter (aus) leading to it being previously removed. A new aus system was implanted in a posterior surgery. The new implant was tested and was found to be fully functional. The patient did not experience any further complications. It was further reported that infection was treated by removing the existing device and treating the patient with medicine. The suspected reason for the urethral erosion and infection was that the 3. 5 cm cuff was likely on too tight. There were no device malfunctions associated with the explanted device. The new device was tested and fully functional. 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 | 2183959-2020-01673 |
| MDR Report Key | 9892252 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-11-05 |
| 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 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 WITH INHIBIZONE |
| Generic Name | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC |
| Product Code | EZY |
| Date Received | 2020-03-27 |
| Model Number | 720157-01 |
| Catalog Number | 720157-01 |
| Lot Number | 1000187259 |
| Device Expiration Date | 2019-11-05 |
| 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 |