BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX MESH

    MDR report key: 3040138 · Received April 3, 2013

    Report

    Report Number
    MW5029630
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BARD MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    PATIENT IS HAVING WHAT APPEARS TO BE A CONTACT DERMATITIS AND SKIN REACTION TO THE MARLEX MESH THERE IS A PERFECTLY DEMARCATED 4 CM X 3.5 CM ERYTHEMATOUS PATCH SUPERIOR TO THE INGUINAL HERNIA INCISION SITE. PERSISTENT RASH WITH NO RESOLUTION FROM TOPICAL STEROIDS AND ANTIHISTAMINES. HE HAS WHAT APPEARS TO BE BODY WIDE REACTION (URTICARIA) AS WELL, WITH NO RESOLUTION FROM ANTIHISTAMINES AND TOPICAL STEROIDS. A PATCH TEST WAS PERFORMED AND PATIENT HAS ALLERGY TIXOCORTOL-21-PIVALATE AND COBALT DICHLORIDE. PREVIOUS RX FOR STEROIDS WERE STOPPED DUE TO ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136275 MARLEX MESH CRYSTALLINE POLYPROPYLENE FTL BARD MEDICAL HUVF0860

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other