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

Model Number 31633

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.Device evaluated by manufacturer? not returned.

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 infected mesh, additional surgery, loculated mesh, non-healing and open wound, wound vac, extensive adhesions, lysis of adhesions, hernia recurrence, umbilical drainage, and pain.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.

Manufacturer Narrative

Additional information section: a2, b5, b7, d4, h4, h6.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 requirements.

Event Description

Plaintiff also allegedly experienced debridement.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10118506
• MDR Text Key: 193965614
• Report Number: 3011175548-2020-00764
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: 31633
• Device Catalogue Number: 31633
• Device Lot Number: 10718426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention