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

Model Number 31526

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 01/07/2011

Event Type  Injury  

Event Description

Received a medwatch stating that pt underwent a repair of hernia.Pt reported further surgeries due to pain, adhesions and mesh rejection.(b)(4).

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4811381
• MDR Text Key: 5927267
• Report Number: 1219977-2015-00158
• 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
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2013
• Device Model Number: 31526
• Device Catalogue Number: 31526
• Device Lot Number: 10659442
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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