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

Device Problem Entrapment of Device (1212)

Patient Problem Adhesion(s) (1695)

Event Type  Injury  

Event Description

Received a medwatch stating that pt underwent a repair of ventral hernia and removal of tumor.Some time thereafter the mesh became intertwined with intestines, bowel, and adhered to colon.Approx 17 months later underwent an open repair of the incarcerated mesh.

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: 4792730
• MDR Text Key: 18086909
• Report Number: 1219977-2015-00153
• 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: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 05/21/2015
• 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