MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V-PATCH

Model Number 31201

Device Problems Folded (2630); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The surgeon are having difficulty with the mesh "balling up (forming into a ball).The surgeon has stated they had to remove 4 meshes over the past 6 months or so due to this "balling effect".The surgeon claims the mesh is not integrated.The surgeon has admitted it might be his technique.Each explanted piece of mesh has been explanted and sent for cultures.No infection present in any of the explanted mesh.

Manufacturer Narrative

We are unable to perform a full investigation as no sample, product code or lot number was available.Review of complaints does not show any similar reports related to a device failure.If any further information is provided a follow up report will be submitted.The other related reports are: 1219977-2014-00094, 00096, 00097.

• Brand Name: C-QUR V-PATCH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, manager ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687872
• MDR Text Key: 4298110
• Report Number: 1219977-2014-00095
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31201
• Device Catalogue Number: 31201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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