MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-14 for AMS SLING SYSTEM UNK-P-SLING-MENS manufactured by Boston Scientific Corporation.
[179448129]
It was reported that the patient experienced unspecified issues with a sling device leading to an artificial urinary sphincter (aus) being implanted. No information was provided about the patient's outcome. It was further reported that the patient experienced recurring incontinence leading to the procedure and needed more than three pads daily. The onset of the incontinence was unknown and there were no device malfunctions associated with the sling. The patient did not experience any further adverse events. 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 | 2183959-2020-00694 |
| MDR Report Key | 9711440 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-14 |
| 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 SLING SYSTEM |
| Generic Name | MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE |
| Product Code | OTM |
| Date Received | 2020-02-14 |
| Model Number | UNK-P-SLING-MENS |
| Catalog Number | UNK-P-SLING-MENS |
| 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 | 2020-02-14 |