BEUDAMED
    FDA Adverse Event Summary report: N

    BARD "3D MAX" MESH

    MDR report key: 2855969 · Received November 28, 2012

    Report

    Report Number
    MW5027856
    Date Received
    November 28, 2012
    Date of Event
    June 22, 2009
    Report Date
    November 15, 2012
    Manufacturer
    DAVOL, A BARD COMPANY
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, I UNDERWENT SURGERY FOR A RIGHT INGUINAL HERNIA. THE NEXT DAY WHILE AT HOME I EXPERIENCED AN EXTREMELY SHARP PAIN ON MY RIGHT SIDE AND IT HAS PERSISTED TO THIS DAY. I HAD SEEN SEVERAL DIFFERENT DOCTORS OVER THE YEARS, WENT FOR PAIN MANAGEMENT AND EVEN PHYSICAL THERAPY. I HAD TO LEAVE MY JOB A YEAR LATER AND I AM CURRENTLY RECEIVING (B)(6). AFTER EXTENSIVE RESEARCH AND DOCTOR VISITS, MOST RECENTLY THIS PAST (B)(6) FOR ANOTHER FOLLOW UP VISIT REGARDING THE 'HERNIA' PAIN, THE ONLY CONCLUSION IS A PROBLEM WITH THE MESH. THE MANUFACTURER DOES HAVE RECALLS FOR THEIR MESH PRODUCT BUT APPARENTLY NOT FOR THE 3D MAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD "3D MAX" MESH MESH FTL DAVOL, A BARD COMPANY HUTC 1263

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability