MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH

Model Number 31536

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 06/09/2013

Event Type  Injury  

Manufacturer Narrative

This event is under investigation and upon completion, a f/u report will be submitted.

Event Description

The dr implanted the original sheet of c-qur mesh in an open procedure. Wand could not get adequate peritoneal coverage and nor re-approximate the facia. Dr could not get the mesh to sit completely flat so used a technique which involves splitting the mesh and pleating it over and suturing it back together as a means of tightening it once it has been fixated lateral to the defect. The dr has been using c-qur mesh to do similar procedures for years. This time had to go back in only 3 days later for reasons that not make clear. When first saw the mesh the 03fa adhesion barrier remained intact. At some point during the second procedure noticed that a large portion of the adhesion barrier had simply fallen off of the mesh and was resting on bowel. Dr then removed the uncoated c-qur mesh and replaced it with a new piece of c-qur mesh. The dr felt the issue may have been related to the folding of the mesh so tried to keep the second piece as flat as possible in order to avoid a similar result. Dr reported the next piece has worked well.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: theresa morin, mgr. ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3282516
• MDR Text Key: 11009579
• Report Number: 1219977-2013-00121
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/28/2016
• Device Model Number: 31536
• Device Catalogue Number: 31536
• Device Lot Number: 10878121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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: 08/06/2013 Patient Sequence Number: 1