BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM PRO LOOP MESH AND PLUG

    MDR report key: 3896134 · Received June 20, 2014

    Report

    Report Number
    MW5036802
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 10, 2010
    Report Date
    June 19, 2014
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD INGUINAL HERNIA SURGERY ON (B)(6) 2010. I HAD ATRIUM MEDICAL'S PRO LOOP MESH AND PLUG USED. IT HAS MADE MY LIFE UNBEARABLE! THE PAIN CONTINUES TO GET WORSE, I AM ALSO NOW ON DISABILITY. I CAN'T FIND A SURGEON TO TAKE IT OUT. ATRIUM MEDICAL NEEDS TO BE HELD ACCOUNTABLE. PLEASE RECALL THIS HORRIBLE MESH PRODUCT! MY QUALITY OF LIFE HAS GONE DOWN SO FAR I AM TOO DEPRESSED AND IN TOO MUCH PAIN TO CONTINUE MY ACTIVITIES I USED TO ENJOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363375 ATRIUM PRO LOOP MESH AND PLUG PRO HOOP MESH PLUG FTL ATRIUM MEDICAL ATRIUM PRO LOOP POLYPROPELENE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| S