MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH, LLC AMS INTEXEN-PORCINE DERMIS

Catalog Number 72404064

Device Problem Insufficient Information (3190)

Patient Problem Emotional Changes (1831)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress and a product problem.The device remains implanted.No further complications have been reported in relation to this event.

• Brand Name: AMS INTEXEN-PORCINE DERMIS
• Type of Device: NA
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH, LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH, LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer Contact: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5949106
• MDR Text Key: 54659945
• Report Number: 3011770902-2016-12745
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2011
• Device Catalogue Number: 72404064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2010
• 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: GYNECARE PROLIFT; GYNECARE TVT SECUR; PARIETEX
• Patient Outcome(s): Disability
• Patient Weight: 64