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

Model Number 31228

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scarring (2061); 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.

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.

Event Description

Plaintiff allegedly also experienced chronic sinus, purulent drainage, granulation tissue and inflammation.

• Brand Name: C-QUR EDGE
• 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: 7408771
• MDR Text Key: 104752023
• Report Number: 3011175548-2018-00334
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K080691
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Model Number: 31228
• Device Catalogue Number: 31228
• Device Lot Number: 10312206
• Other Device ID Number: 00650862312287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 07/12/2018
• Date Device Manufactured: 01/23/2008
• 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