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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fistula (1862)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation into this event has been completed.
 
Event Description
Received report of an event of fistula following patient being implanted with mesh.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided. There is no indication that this event is due to a device failure. Clinical evaluation: fistulas are a known complication of incisional hernia repairs using prostheses. Risk factors include surgical technique used in fixation, presence of suture abscesses, and patient factors including obesity, smoking, diabetes mellitus, elder age and poor nutritional status. Fistulas are a late complication of repairs with mesh particularly if the mesh is in direct contact with the intestine and may be caused by chronic infection. Drainage creates a tract from one space to another, this is called a fistula. The instructions for use state complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection and fistula formation, mechanical disruption of the tissue and/or mesh material when placed in direct contact with the viscera and organs.
 
Manufacturer Narrative
Corrected report date.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6142172
MDR Text Key61351871
Report Number1219977-2016-00244
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2011
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: 12/02/2016 Patient Sequence Number: 1
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