MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS INTEXEN-PORCINE DERMIS

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 device remains implanted.No further complications have been reported in relation to this event.

Manufacturer Narrative

(b)(6).Total number of events summarized - (b)(4) ams intexen-porcine dermis -.

• Brand Name: AMS INTEXEN-PORCINE DERMIS
• Type of Device: NA
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren rd w; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4853693
• MDR Text Key: 5873087
• Report Number: 2183959-2015-13740
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFAST SLING
• Patient Outcome(s): Disability