MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH C-QUR LITE CENTRIFX MESH, SURGICAL, POLYMERIC

Model Number 31395

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

Patient Problems Pain (1994); Scarring (2061)

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 potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product. Plaintiff allegedly experienced pain, scarring, torn labrum, herniated disc, and additional medical procedures as a result of the implantation of the mesh implant.

• Brand Name: MESH C-QUR LITE CENTRIFX
• 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: 40 continental blvd; merrimack, NH
• MDR Report Key: 10941508
• MDR Text Key: 219382662
• Report Number: 3011175548-2020-01400
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862313956
• UDI-Public: 00650862313956
• Combination Product (y/n): N
• PMA/PMN Number: K110110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/01/2018
• Device Model Number: 31395
• Device Catalogue Number: 31395
• Device Lot Number: 404247
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/03/2020 Patient Sequence Number: 1