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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Seroma (2069)

Event Type  Injury  

Event Description

The pt presented a leakage of yellow liquid through the surgical wound, seroma and chronic pain after implantation of the mesh.The mesh was explanted.The mesh was not infected.

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 V PATCH
• 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: 4107037
• MDR Text Key: 17993841
• Report Number: 1219977-2014-00298
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K090909
• 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: 55 YR
• Patient Weight: 100