MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INFAST SLING; MESH, SURGICAL, POLYMERIC

Model Number 72403885

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced an unspecified injury.The mesh remains implanted.No further patient complications have been reported in relation to this event.

Manufacturer Narrative

(b)(4).Total number of events summarized - (b)(4).Infast sling - (b)(4).

• Brand Name: INFAST SLING
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4542234
• MDR Text Key: 17946626
• Report Number: 2183959-2014-76699
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2009
• Device Model Number: 72403885
• Device Lot Number: 533191
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REPLIFORM
• Patient Outcome(s): Disability