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

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

Patient Problems Fistula (1862); Cancer (3262)

Event Type  Injury  

Event Description

Received a report that a patient developed a fistula after being implanted with a mesh device.The mesh was implanted for abdominal reconstruction.Eight months before fistula became apparent.

Manufacturer Narrative

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

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 3853037
• MDR Text Key: 19768192
• Report Number: 1219977-2014-00164
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ETIBON-POLIESTER
• Patient Outcome(s): Other