INFAST SLING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2013-01-16 for INFAST SLING SYSTEM manufactured by American Medical Systems, Inc..

Event Text Entries

[3215851] It was reported by the plaintiff's attorney that the plaintiff experienced emotional distress and a problem with the product. The device was implanted for treatment.
Patient Sequence No: 1, Text Type: D, B5

[10446973] Should additional info become available regarding this event it will be re-evaluated and a follow-up report will be sent as appropriate. Lawyer-filed report - (b)(4).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2183959-2013-00249
• MDR Report Key: 2926300
• Report Source: 00,04
• Date Received: 2013-01-16
• Date of Report: 2012-12-05
• Date Mfgr Received: 2012-12-07
• Date Added to Maude: 2013-01-24
• 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: 0
• Event Location: 0
• Manufacturer Contact: SHARON ZURN, DIRECTOR
• Manufacturer Street: 10700 BREN RD., WEST
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal: 55343
• Manufacturer Phone: 9529306347
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INFAST SLING SYSTEM
• Generic Name: SURGICAL MESH
• Product Code: GAS
• Date Received: 2013-01-16
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2013-01-16