BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX E/X MESH

    MDR report key: 1103424 · Received August 5, 2008

    Report

    Report Number
    MW5007931
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    June 25, 2007
    Report Date
    August 5, 2008
    Manufacturer
    DAVOL COMPANY
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2007. I HAD TO HAVE SURGERY TO REMOVE MESH THAT WAS IMPLANTED IN ME IN 2004 FOR A HERNIA SURGERY. IT FELT LIKE I HAD LUMPS ALL INSIDE OF ME AND IT CAUSED ME TO HAVE EXTREME PAIN. THE DOCTOR THAT DID THE SURGERY TOLD ME IT WAS A MESS INSIDE OF ME, IT TOOK HER HOURS TO PICK ALL OF THE MESH OUT. THIS WAS BECAUSE IT BROKE UP AND WAS STUCK IN MY INTESTINES. THE MESH THAT WAS USED WAS MANUFACTURED BY DAVOL BARD CALLED BARD COMPOSIX E/X MESH ELLIPSE LOT 43FND319 AND LOT 43BOD398. I REPORTED THIS TO THE COMPANY, I HAVE NOT HEARD FROM THEM AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX E/X MESH SURGICAL MESH FTL DAVOL COMPANY 0123460 43FND319
    2 BARD COMPOSIX E/X MESH SURGICAL MESH FTL DAVOL COMPANY 0123680 43BOD398

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S