MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for AMS SLING SYSTEM UNK-P-SLING-MENS manufactured by Boston Scientific Corporation.
[186370994]
It was reported that an unspecified sling was implanted on an unspecified date. An artificial urinary sphincter (aus) device was later implanted due to unspecified reasons. Additional information received states the patient began experiencing urinary incontinence following a prostatectomy. The patient was implanted with an ams sling device in 2012. After implantation with the sling the patient's incontinence improved and he was using two pads per day. The ams sling was later removed in 2019 due to unspecified reasons and a atoms sling was implanted. After the atoms sling was implanted the patient experienced no improvement in incontinence and was using 8 pad per day. The patient was then later implanted with an aus device in 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01597 |
| MDR Report Key | 9881293 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 | 4089353452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 10700 BREN ROAD WEST |
| 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 | 2020-03-25 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-25 |