BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD FLAT MESH

    MDR report key: 2287396 · Received October 7, 2011

    Report

    Report Number
    1213643-2011-00512
    Event Type
    Death
    Date Received
    October 7, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 14, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORT TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED NO DEVICE FAILURE HAS OCCURRED. THE PATIENT REPORTEDLY HAD A KNOWN ALLERGY TO POTASSIUM DICHROMATE AND IT WAS REPORTED THE PATIENT HAD ELEVATED LEVELS OF POTASSIUM DICHROMATE AND CHROMATE/CHROMIUM IN HIS BLOOD SERUM. DAVOL HAS REVIEWED THE MANUFACTURING PROCESS AND HAS DETERMINED THERE ARE NO CHEMICALS OR FIXTURES USED THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE SUPPLIER OF THE POLYPROPYLENE RESIN HAS PROVIDED A CERTIFICATE OF COMPLIANCE AND (B)(6) CERTIFICATION FOR THE MOST CURRENT SHIPMENT OF RESIN. THE CERTIFICATE OF COMPLIANCE VALIDATES THE MATERIAL IS POLYPROPYLENE RESIN IN ACCORDANCE WITH DAVOL'S RAW MATERIAL SPECIFICATION. THE COMPLAINANT HAS NOT PROVIDED A LOT NUMBER THEREFORE THE CERTIFICATE OF COMPLIANCE IS FOR THE LAST SHIPMENT OF RESIN. THERE HAVE BEEN NO CHANGES IN THE PROCESS, PRODUCT OR YARN PROPERTIES. THE PATIENT'S DAUGHTER REPORTED THE MESH WAS RETRIEVED DURING AN AUTOPSY BUT IT HAS NOT BEEN PROVIDED FOR EVALUATION. ADDITIONALLY, THE COMPLAINANT HAS DECLINED TO PROVIDE MEDICAL RECORDS, DEATH CERTIFICATE, AUTOPSY OR DETAILS SURROUNDING THE EVENT. BASED ON THE INFORMATION PROVIDED, MANUFACTURING REVIEW, LABELING REVIEW, AND SUPPLIER CERTIFICATION, NO DEVICE FAILURE HAS OCCURRED.

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED TO DAVOL BY THE PATIENT'S DAUGHTER: ON (B)(6) 2011 - THE PATIENT UNDERWENT REPAIR OF A INGUINAL HERNIA WITH BARDFLAT MESH. ON (B)(6) 2011 - THE PATIENT EXPERIENCED UNKNOWN COMPLICATIONS. ON (B)(6) 2011 - THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death