MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS AMS INTEXEN-PORCINE DERMIS; MESH, SURGICAL

Device Problem Extrusion (2934)

Patient Problem Injury (2348)

Event Date 02/02/2012

Event Type  Injury  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced mesh exposure.The plaintiff underwent revision surgery wherein the device was partially explanted.No further complications have been reported in relation to this event.

Manufacturer Narrative

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

• Brand Name: AMS INTEXEN-PORCINE DERMIS
• Type of Device: MESH, SURGICAL
• 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: 4712612
• MDR Text Key: 21188317
• Report Number: 2183959-2015-13188
• 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: Attorney
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARC
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 77