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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Twenty months after hernia surgery, pt experienced chronic pain and had mesh explanted.Performed laparotomy and found the mesh not attached to the abdominal wall, but attached to several loops of intestine instead.The mesh was not infected, the culture results were negative.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the f/u report once the eval is completed.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4107031
• MDR Text Key: 22000546
• Report Number: 1219977-2014-00301
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• 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: 08/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABSORBABLE TACKS
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 100