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

Model Number 31202

Device Problem Material Twisted/Bent (2981)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Investigation: 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 recurrent hernia and balled up mesh, and revision surgery, incisional hernia, ventral hernia, pain, adhesions, unincorporated mesh, enterotomy, serosal injury and wound contamination.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.

• Brand Name: C-QUR V-PATCH
• 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: 8360208
• MDR Text Key: 136841861
• Report Number: 3011175548-2019-00193
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312027
• UDI-Public: 00650862312027
• Combination Product (y/n): N
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 10870368
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2013
• 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
• Patient Age: 61 YR