MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for AMS SLING SYSTEM UNK-P-SLING-MENS manufactured by Boston Scientific Corporation.
[185914272]
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed. The event cannot be reproduced or substantiated.
Patient Sequence No: 1, Text Type: N, H10
[185914273]
It was reported that research an development engineer was observing market research/ voice of customer (voc) when a patient indicated that he had a sling implanted in 2000 and during the procedure his nerves were crushed and it caused significant pain. It is unknown if this was a bsc sling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01772 |
| MDR Report Key | 9908136 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2000-01-01 |
| Date Mfgr Received | 2020-03-15 |
| Date Added to Maude | 2020-03-31 |
| 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 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 | 2020-03-31 |
| Model Number | UNK-P-SLING-MENS |
| Catalog Number | UNK-P-SLING-MENS |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-31 |