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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-09 for * manufactured by American Medical Systems.

Event Text Entries

[2275323] A malfunction of the urinary sphincter occurred. There was loss of fluid from the implant. The mfr response for the urinary sphincter, per site reporter, is ams wants the sphincter returned to determine the problem. There was a pin hole leak in the systemm and fluid leaks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2351133
• MDR Report Key: 2351133
• Date Received: 2011-11-09
• Date of Report: 2011-11-09
• Date of Event: 2011-10-27
• Report Date: 2011-11-09
• Date Reported to FDA: 2011-11-09
• Date Added to Maude: 2011-11-29
• 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
• 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 Details

• Brand Name: *
• Generic Name: URINARY SPHINCTER
• Product Code: FAG
• Date Received: 2011-11-09
• Model Number: *
• Catalog Number: *
• Lot Number: 706637012,699372005, 703449012
• ID Number: *
• Device Availability: Y
• Device Age: 8 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS
• Manufacturer Address: 10700 BREN RD W MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-11-09