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

Model Number 31202

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Fibrosis (3167)

Event Date 04/07/2014

Event Type  Injury  

Event Description

Report received stated the patient had a repair of an incision al hernia.The mesh formed a lump and fibrosis was seen and had to be removed.

Manufacturer Narrative

We are currently awaiting the return of the device for investigation.A follow-up report shall be submitted once the evaluation is completed.

• Brand Name: C-QUR V PATCH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3827016
• MDR Text Key: 22138747
• Report Number: 1219977-2014-00148
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• 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
• Patient Outcome(s): Required Intervention