MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-28 for AMS ADVANCE XP SLING SYSTEM 720163-01 manufactured by Boston Scientific Corporation.
[181479402]
Date of event entered is an estimated date as the exact date of event was not provided.
Patient Sequence No: 1, Text Type: N, H10
[181479403]
It was reported that following implantation with an advance xp sling device the patient stated he was more incontinence and was dissatisfied with the results of the procedure. No interventions have been taken. Additional information received states that prior to having the sling implanted the patient used 2 pads per day. Following implantation with the sling the patient was still using 2 pads per day. The patient had "perineal pain in the postoperative" period. There is no planned intervention at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-00960 |
| MDR Report Key | 9772043 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-02-28 |
| 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 | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| 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 | 2020-02-28 |
| Model Number | 720163-01 |
| Catalog Number | 720163-01 |
| Lot Number | 0023970060 |
| 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 | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |