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

Model Number 31201

Device Problems Material Invagination (1336); Migration (4003)

Patient Problems Unspecified Infection (1930); Pain (1994); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Investigation: 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.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 medicals mesh product.Plaintiff allegedly experienced infection, mesh rolled up, mesh migration, additional surgery, pain and suffering.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 also allegedly experienced drainage.

• Brand Name: MESH C-QUR V-PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11681017
• MDR Text Key: 250182851
• Report Number: 3011175548-2021-00414
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312010
• UDI-Public: 00650862312010
• 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,Followup
• Report Date: 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 31201
• Device Catalogue Number: 31201
• Device Lot Number: 10813753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention