BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 607683 · Received May 18, 2005

    Report

    Report Number
    1213643-2005-00074
    Event Type
    Injury
    Date Received
    May 18, 2005
    Date of Event
    April 28, 2005
    Report Date
    May 2, 2005
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MESH USED FOR INCISINAL HERNIA REPAIR POST CHOLESYSTECTOMY - 0112660, LOT #43EMD301. PATIENT DEVELOPED INFECTION AND FLAT MESH WAS REMOVED. COMPOSIX WAS USED IN ITS PLACE IN INFECTED AREA. PATIENT WENT INTO SEPTIC SHOCK. INCIDENT NOT REPORTED BY THE HOSPITAL. PATIENT COMPLAINED TO NEW YORK STATE DEPARTMENT OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. * 43DMD034

    Patients

    Seq Age Sex Outcome Treatment
    1 *