BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX E/X MESH 4"X6"

    MDR report key: 2617637 · Received June 12, 2012

    Report

    Report Number
    MW5025779
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 6, 2012
    Manufacturer
    DAVOL INC. TECHNOLOGY
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A VENTRAL HERNIA REPAIR (B)(6) 2002 WITH BARD COMPOSIX E/X MESH 4¿X6¿ PRODUCT CODE (B)(4), LOT #: 43HMD234. TEN YEARS LATER, THIS PT EXPERIENCED ABDOMINAL PAIN, DIFFICULT BOWEL MOVEMENTS, NAUSEA AND VOMITING. PT RETURNED TO SURGERY TO REMOVE THE MESH AND REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX E/X MESH 4"X6" NONE FTL DAVOL INC. TECHNOLOGY 0123460 43HMD234

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention