BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL BARD COMPOSIX MESH

    MDR report key: 856652 · Received May 22, 2007

    Report

    Report Number
    MW5001963
    Event Type
    Injury
    Date Received
    May 22, 2007
    Date of Event
    December 28, 2005
    Report Date
    May 22, 2007
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    IN 2005, I HAD HERNIA SURGERY PERFORMED AT THE HOSPITAL BY THE DR. AFTER THE SURGERY WAS PERFORMED, I CONTINUED TO SEE THE DR. IN 2006, BECAUSE MY INCISION WOULD NOT HEAL. IT WOULD NOT CLOSE AND DRAINED EVERY DAY. AFTER THE DRAIN TUBE CAME OUT, IT DEVELOPED A POCKET THAT CONTINUED TO DRAIN. I WAS ON ANTIBIOTICS UNTIL 2006, AT WHICH TIME THE DR. TOOK ME OFF OF THEM AND SCHEDULED ME FOR SURGERY TO REMOVE THE MESH. THE MESH THAT WAS USED IN MY SURGERY WAS COMPOSIX MESH. THE PAPERS STATED IT WAS DAVOL BARD COMPOSIX E/X MESH; ELLIPSE 10"X13", REF 0123113, LOT 43GOD202. THE ENTIRE PIECE OF MESH HAD TO BE REMOVED BECAUSE IT WAS INFECTED THE ENTIRE LENGTH OF THE SURGERY. THE DOCTOR AND NURSES SAID THAT THEY HAD NEVER SEEN ANY MESH LIKE IT. IT WAS AS THOUGH THERE WAS A THIN PIECE OF PLASTIC SEWN ONTO THE MESH THAT WOULD NOT ALLOW IT TO HEAL. THE SURGERY TO REMOVE THE MESH WAS COMPLETED AND AFTER BEING LEFT OPEN FOR 9-NINE-DAYS TO PERMIT IT TO HEAL FROM THE INSIDE, THEN IT WAS SEWN UP ON THE OUTSIDE, ALL THIS TIME WAS SPENT IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL BARD COMPOSIX MESH NONE FTL ELLIPSE -10"X13"- 43GOD202

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| S