CUFF AMS 800 4.0 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-25 for CUFF AMS 800 4.0 * manufactured by American Medical Systems, Inc..

Event Text Entries

[2295668] A pt had an artificial urinary sphincter implanted last month. The device was removed last week. The operative report indicates a "malfunction of artificial urinary sphincter. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2324989
• MDR Report Key: 2324989
• Date Received: 2011-10-25
• Date of Report: 2011-10-25
• Date of Event: 2011-10-14
• Report Date: 2011-10-25
• Date Reported to FDA: 2011-10-25
• Date Added to Maude: 2011-11-04
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CUFF AMS 800 4.0
• Generic Name: ARTIFICIAL URINARY SPHINCTER
• Product Code: FAG
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 10700 BREN RD. WEST EDEN PRAIRIE MN 55343 US 55343

Device Sequence Number: 2

• Brand Name: SPHINCTER BALLOON 61-70 AMS 800
• Generic Name: ARTIFICIAL URINARY SPHINCTER
• Product Code: FAG
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC
• Manufacturer Address: 10700 BREN RD WEST EDEN PRAIRIE MN 55343 US 55343

Device Sequence Number: 3

• Brand Name: PUMP AMS 800 SPHINCTER CONTROL
• Generic Name: ARTIFICIAL URINARY SPHINCTER
• Product Code: FAG
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC
• Manufacturer Address: 10700 BREN RD WEST EDEN PRAIRIE MN 55343 US 55343

Device Sequence Number: 4

• Brand Name: KIT ,AMS 800 ,SPHINCTER ACCESSORY
• Generic Name: ARTIFICIAL URINARY SPHINCTER
• Product Code: FAG
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 10700 BREN RD. WEST EDEN PRAIRIE MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-10-25