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

Model Number 31533

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Adhesion(s) (1695)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.

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 shrinkage of the mesh resulting in recurrence and a second surgery, there were dense adhesions that had to be lysed.

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

Plaintiff allegedly also experienced misshapen mesh.

• Brand Name: C-QUR MESH
• 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: 7095488
• MDR Text Key: 94119446
• Report Number: 3011175548-2017-00353
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: 31533
• Device Catalogue Number: 31533
• Device Lot Number: 10552811
• Other Device ID Number: 00650862315332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• Date Device Manufactured: 10/21/2009
• 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