MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-27 for AMS SLING SYSTEM UNK-P-SLING-MENS manufactured by Boston Scientific Corporation.
[181921752]
It was reported that patient stated he had the advance male sling placed on (b)(6) 2019 and he said it was too tight, worked then did not work. He went in again on (b)(6) 2020 and he said the bulb for the catheter was inflated prematurely and it twisted. Patient did not provide his surgeon name as he said he will not be using them again, they wanted him to go in for a 3rd revision right after the 2nd. He said he was in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00920 |
| MDR Report Key | 9762709 |
| Report Source | CONSUMER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-27 |
| 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 | 4089353452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 10700 BREN ROAD WEST |
| Manufacturer City | MIINNETONKA 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 | 2020-02-27 |
| 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 | 2020-02-27 |