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

Model Number 31628 - C-QUR TACHSHIELD 4X6 (10CMX 15CM)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Adhesion(s) (1695); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

Based on the review of the device history and sterilization 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 is named as a defendant.

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 additional surgery, infected and wadded up mesh, incision and drainage of infected abdominal wall abscess with subfascial extension, draining sinus, recurrent incisional hernia, repaired with placement of new mesh, adhesions, pain.Suture granuloma, granulation tissue, staph aureus, inflammation, debridement and sinus tract.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.

• Brand Name: C-QUR TACHSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12465662
• MDR Text Key: 271215134
• Report Number: 3011175548-2021-00950
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862316285
• UDI-Public: 00650862316285
• 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
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 31628 - C-QUR TACHSHIELD 4X6 (10CMX 15CM)
• Device Catalogue Number: 31628
• Device Lot Number: 10849889
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention