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

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

Patient Problems Pain (1994); Seroma (2069)

Event Type  Injury  

Event Description

Eighteen months after surgery, pt experienced seroma, chronic pain, and a skin reaction.The mesh was explanted.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 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: 4107033
• MDR Text Key: 4697415
• Report Number: 1219977-2014-00302
• 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

• 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
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 09/11/2014
• 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 SUTURES
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 90