BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DMAX MESH

    MDR report key: 8843459 · Received July 29, 2019

    Report

    Report Number
    MW5088548
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    March 30, 2016
    Report Date
    July 29, 2019
    Manufacturer
    DAVOL, INC. SUB. C. R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT AN ADVERSE EVENT INVOLVING HIS 3DMAX MESH HE HAD IMPLANTED ON (B)(6) 2016. PT STATED 6 WEEKS AFTER SURGERY, HIS SWELLING BECAME WORSE. PT STATED HE WAS IN SEVERE PAIN, HAD COMPLICATIONS WITH BOWEL MOVEMENTS, AND CITRUS FOODS AND TOMATO CAUSE UPSET HIM. PT SAID HE WENT TO THE EMERGENCY ROOM (ER) 3 TIMES, THE LAST TIME WAS THE FRIDAY AFTER (B)(6) IN 2018, WHERE HE WAS REFERRED TO A SURGEON. PT SAID HE SAW THE SURGEON THE FOLLOWING WEEK AND WAS TOLD THE MESH NEEDED TO BE REMOVED. PT HAD THE MESH REMOVED ON (B)(6) 2018 AND HAD A DIFFERENT MESH PUT IN. PT STATED HIS COMPLICATION WAS IDENTIFIED AS "MESHOMA", WHERE THE MESH CAME LOOSE FROM THE SUTURES AND BECAME ROLLED UP INSIDE HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628761 3DMAX MESH MESH, SURGICAL, POLYMERIC FTL DAVOL, INC. SUB. C. R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization