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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Occlusion (1984); Pain (1994)

Event Type  Injury  

Event Description

Mesh removed 12 days after surgery.The pt had pain and intestinal occlusion.Underwent laparotomy and found the mesh attached to several loops of small intestine.Culture results came back negative for infection.

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 TACSHIELD
• 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: 4107017
• MDR Text Key: 17998884
• Report Number: 1219977-2014-00300
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K100076
• 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
• 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
• Treatment: PERMANENT TACKS
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100