BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSH MESH

    MDR report key: 5384776 · Received January 19, 2016

    Report

    Report Number
    MW5059546
    Event Type
    Injury
    Date Received
    January 19, 2016
    Date of Event
    June 13, 2014
    Report Date
    January 19, 2016
    Manufacturer
    ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ETHICON PSH MESH IMPLANTED TO RIGHT GROIN IN (B)(6) OF 2004. IN (B)(6) 2014, STARTED HAVING SEVERE PAIN TO RIGHT GROIN. HAD MULTIPLE SCANS AND TESTS. FOUND THAT MESH WAS THE PROBLEM. HAD ILLIOINGUINAL NERVE ABLATION BUT DID NOT HELP. SURGEON SAYS ONLY TAKING MESH OUT WILL HELP, BUT THERE ARE SERIOUS RISKS AND A 30 PERCENT CHANCE OF NOT HELPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37469 PSH MESH PSH MESH FTL ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability