BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX HERNIA MESH

    MDR report key: 8632169 · Received May 21, 2019

    Report

    Report Number
    MW5086819
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    November 24, 2015
    Manufacturer
    DAVOL INC., SUB. C. R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, I HAD SURGERY, A REPAIR OF UMBILICAL HERNIA WITH MEDIUM VENTRALEX PATCH. SHORTLY THEREAFTER EXCRUCIATING PAIN AND SORENESS, AND EVER SINCE THE OPERATION. THE OPERATION WAS CONDUCTED IN 2015, AND THE PAIN STILL PERSISTS, AND IT IS NOW 2019. RESERVED FOR A LATER DATE AND TIME. ATRIUM MEDICAL CORPORATION. REASON FOR USE: TO REPAIR UMBILICAL HERNIA, AND TO ALLEVIATE PAIN/SUFFERING. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423676 VENTRALEX HERNIA MESH MESH, SURGICAL, POLYMERIC FTL DAVOL INC., SUB. C. R. BARD, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR