MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-25 for AMS ADVANCE XP SLING SYSTEM 720163-01 manufactured by Boston Scientific Corporation.
[180722683]
It was reported that the patient presented stress incontinence with his advance sling. The patient had a urethral injury. Additional information received. The procedure was aborted due to the needle passed through urethra. Urinary incontinence was the baseline that lead to the sling implant procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00863 |
| MDR Report Key | 9749586 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-09-20 |
| Date Added to Maude | 2020-02-25 |
| 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 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 ADVANCE XP SLING SYSTEM |
| Generic Name | MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE |
| Product Code | OTM |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-11 |
| Model Number | 720163-01 |
| Catalog Number | 720163-01 |
| Lot Number | 0024809723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-25 |