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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Patient reported that she had a mesh implanted in 2013, for a very large "swiss cheese" hernia. The mesh had to be removed in (b)(6) 2015 due to complications.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided. Clinical evaluation: hernias emerge through preformed or acquired defects or weak areas of the abdominal wall unprotected by muscle or aponeurosis. There are dozens of types and subtypes of abdominal wall hernias, ranging from the simple groin hernia to the complex and rare. A "swiss cheese hernia" occurs when multiple hernia sites occur in a localized area of the abdominal wall. It was reported that the patient required explant of the mesh due to unspecified complications follow the repair of a very large complex and rare hernia. Complications may occur due to a technical error, inadequate suture fixation and/or inadequate overlap which will cause separation of the mesh from the abdominal wall thereby increasing the possibility of infection, perforation, seroma, adhesions, fistula formation and pain. The compromised patient undergoing a second surgery for explant has increased risks. The instructions for use state complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines).
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5201388
MDR Text Key30394757
Report Number1219977-2015-00321
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2015
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 Treatment Data
Date Received: 11/04/2015 Patient Sequence Number: 1
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