BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CQUR MESH

    MDR report key: 3134106 · Received May 23, 2013

    Report

    Report Number
    1219977-2013-00072
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATRIUM MEDICAL DOES NOT BELIEVE THAT THIS MALFUNCTION REPORT OF THE BARRIER COATING STICKING TO THE HANDLING SLEEVE WOULD BE LIKELY TO RESULT IN DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. ATRIUM MEDICAL IS FILING THIS REPORT AS WE RECEIVED A MEDWATCH REPORT FROM FDA ON (B)(4) 2013. OUR REPORT IS TO PROVIDE FURTHER INFORMATION TO THE AGENCY REGARDING THIS MALFUNCTION. THE DEVICE HISTORY RECORDS FOR THE MESH DEVICE WERE REVIEWED INCLUDING THE STERILIZATION RECORDS, THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS. THE BARRIER COATING OF THE C-QUR MESH PRODUCT STICKING TO THE HANDLING SLEEVE IS IMMEDIATELY APPARENT TO THE USER UPON REMOVING THE PRODUCT FROM THE HANDLING SLEEVE. A SMALL PORTION OF THE BARRIER COATING, APPROXIMATELY 2 PERCENT, WAS TRANSFERRED FROM THE DEVICE TO THE HANDLING SLEEVE. THIS HAS BEEN DETERMINED TO BE A NUISANCE TO THE CLINICIAN, BUT DOES NOT POSE AN UNREASONABLE RISK TO THE HEALTH OF THE PT. THE ACTION REQUIRED WOULD BE FOR THE CLINICIAN TO OBTAIN ANOTHER DEVICE IN PLACE OF THE DEVICE FOUND DEFECTIVE. THIS FAILURE MODE IS ADDRESSED IN OUR FMEA. (B)(4). THE PROBABILITY OF TWO DEVICES EXHIBITING THE SAME PROBLEM IS REMOTE. ALTHOUGH SOME OF THE BARRIER COATING FROM C-QUR MESH IS TRANSFERRED TO THE HANDLING SLEEVE, THE MESH IN THESE AREA STILL HAS SOME BARRIER COATING PRESENT ON THE MONOFILAMENTS. THE BARRIER COATING REMAINING ON THE MONOFILAMENTS WOULD AID IN THE ABILITY OF C-QUR MESH PRODUCTS TO INHIBIT TISSUE ATTACHMENT IN VIVO. ATRIUM MEDICAL MARKETS A MESH PRODUCT WHERE ONLY THE MONOFILAMENTS ARE COATED WITH THE SAM COATING. THESE PRODUCTS HAVE BEEN USED SUCCESSFULLY IN THE MARKET FOR MANY YEARS. A C-QUR MESH PRODUCT THAT HAS STUCK TO THE HANDLING SLEEVE WOULD PERFORM ITS INTENDED USE, "FOR USE IN SOFT TISSUE DEFICIENCIES INCLUDING HERNIA REPAIR, CHEST WALL RECONSTRUCTION, TRAUMATIC OR SURGICAL WOUNDS AND OTHER FASCIAL SURGICAL INTERVENTION PROCEDURES REQUIRING REINFORCEMENT WITH A SUPPORTIVE MATERIAL".

    Description of Event or Problem · 1

    MESH WAS ADHERED TO PACKAGING. WHEN ATTEMPTED TO REMOVE THE MESH, IT STUCK TO THE PACKAGE AND TORE. DEVICE USAGE PROBLEM: DEVICE FAILED (EG, BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228725 CQUR MESH FTL ATRIUM MEDICAL CORP 31536 10828194

    Patients

    Seq Age Sex Outcome Treatment
    1