MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-14 for AMS BALLOON, PUMP manufactured by Ams.
[1204245]
Surgical revision of a malfunctioning artificial urethral sphincter implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010772 |
| MDR Report Key | 1363018 |
| Date Received | 2009-04-14 |
| Date of Report | 2009-04-14 |
| Date of Event | 2009-03-12 |
| Date Added to Maude | 2009-04-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS BALLOON, PUMP |
| Generic Name | ARTIFICIAL URETHRAL SPHINCTER IMPLANT - ACCESSORY KIT |
| Product Code | FAG |
| Date Received | 2009-04-14 |
| Returned To Mfg | 2009-03-12 |
| Lot Number | 578036024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Brand Name | AMS BALLOON, CUFF |
| Generic Name | ARTIFICIAL URETHRAL SPHINCTER IMPLANT - ACCESSORY KIT |
| Product Code | FAG |
| Date Received | 2009-04-14 |
| Returned To Mfg | 2009-03-12 |
| Lot Number | 574586008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-14 |