MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC

Model Number 31633

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Seroma (2069); Discomfort (2330); Fibrosis (3167)

Event Type  Injury  

Manufacturer Narrative

Based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirement.This report is based upon allegations made in a lawsuit in which atrium medical would be named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced severe abdominal pain increasing with activity, pain, discomfort, and tenderness, bowel adhesions, mesh infection, fluid collection/seroma, surgery to repair the hernia, remove infected mesh, mesh protrusion, fibrosis, fistula, mental anguish, severe emotional distress, permanent and severe scarring and disfigurement.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.

Event Description

Plaintiff allegedly also experienced granulation tissue, foreign body giant cell reaction and inflammation.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7408772
• MDR Text Key: 104755760
• Report Number: 3011175548-2018-00335
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 31633
• Device Catalogue Number: 31633
• Device Lot Number: 106994230
• Other Device ID Number: 00650862316339
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2018
• Date Device Manufactured: 10/27/2010
• 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
• Patient Outcome(s): Required Intervention