MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for AMS ARTIFICIAL URINARY SPHINCTER ACCESSORY KIT 800 720066-01 manufactured by American Medical Systems Inc.
[23247533]
Patient Sequence No: 1, Text Type: N, H10
[23247534]
Patient was taken to surgery for replacement of a malfunctioning artificial urinary sphincter. The device was no longer working and patient desired to have it replaced. This device was placed approximately 8 years ago status post radical retropubic prostatectomy and stress incontinence. Four components had been implanted at that time: ams 800 (tm) iz accessory kit ref (b)(4), lot # 515617014; ams press reg balloon ref (b)(4), lot # 512424002 61-70 cm h20; ams 800 control pump with iz ref (b)(4), lot # 508541007; ams s. T. Cuff with iz ref (b)(4), lot # 502270006 4 cm. Patient's post-op course after replacement was routine with no complications. Patient was discharged home the day after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5010031 |
| MDR Report Key | 5010031 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-06-10 |
| Report Date | 2015-08-04 |
| Date Reported to FDA | 2015-08-04 |
| Date Reported to Mfgr | 2015-08-04 |
| Date Added to Maude | 2015-08-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS ARTIFICIAL URINARY SPHINCTER ACCESSORY KIT |
| Generic Name | DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC |
| Product Code | FAG |
| Date Received | 2015-08-18 |
| Model Number | 800 |
| Catalog Number | 720066-01 |
| Lot Number | 515617014 |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS INC |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-18 |