BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFLOR 25MM HERNIA MESH

    MDR report key: 8150965 · Received December 10, 2018

    Report

    Report Number
    MW5081996
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    June 28, 2018
    Report Date
    December 7, 2018
    Manufacturer
    INSIGHTRA MEDICAL INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS HURT ON (B)(6) 2018 AT WORK AND GOT A HERNIA. COMPANY AND INSURANCE COMPANY SENT ME DRS AND THEIR SURGEON, WHO ON (B)(6) 2018 PERFORMED AN OPEN SPIGELIAN HERNIA REPAIR USING INSIGHTRA 25MM PROFLOR MESH. THEIR SURGEON RELEASED ME BACK TO WORK CLAIMING IT WAS SCAR TISSUE AND NERVE PAIN. THEIR INSURANCE IMMEDIATELY CLOSED WORKERS COMP CASE. SO NOW I HAVE BEEN OFF FOR OVER 2 MONTHS WITHOUT ANY INCOME AS THE PAIN I SUFFER HAS KEPT ME FROM WORKING. I HAVE PAIN JUST UNDER INCISION LOCATION, IN GROIN / PELVIC AREA APPROX 3-4" BELOW INCISION AND PAIN TO RIGHT TESTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985098 PROFLOR 25MM HERNIA MESH MESH, SURGICAL, POLYMERIC FTL INSIGHTRA MEDICAL INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability