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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 Pain (1994)
Event Type  Injury  
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided and there is no contact information for the complainant. Clinical evaluation: possible complications that should be considered prior to the use of any surgical mesh include pain, inflammation, recurrence of hernia and seroma to name a few. These complications may be caused by incorrect mesh fixation and stress on the mesh due to activity or body habitus. Complications can occur due to a technical error, inadequate suture fixation and/or inadequate overlap that may lead to mesh contracture and other complications. The fixation technique, method and products used are left solely to the discretion of the surgeon to optimize clinical outcomes. Important aspects of user experience include the necessity of having operative planning with full identification of the extent of the hernia, adept skills in the application of sutures/tacks, and reconstruction skills assuring closure of the wound in layers and coverage of the implanted mesh with minimal space for serous collections and no direct pathway to the mesh from the skin.
 
Event Description
Received a report that a patient had hernia surgery. After awhile patient started having pain. Mesh was removed.
 
Manufacturer Narrative
This follow up report is for the inclusion of report mw5058867.
 
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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 Key5392683
MDR Text Key36893268
Report Number1219977-2016-00017
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 other
Type of Report Initial,Followup
Report Date 01/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
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 Received01/22/2016
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: 01/27/2016 Patient Sequence Number: 1
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