BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVIDON COLLODION REMOVER 128 OZ

    MDR report key: 4771536 · Received May 8, 2015

    Report

    Report Number
    MW5042679
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 8, 2015
    Manufacturer
    MAVIDON
    Product Code
    GYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COLLODION REMOVER (MAVIDON) WAS USED TO REMOVE EEG FROM THIS INFANT WHO WAS ECMO AFTER OPEN HEART SURGERY. SHORTLY THEREAFTER THE PT BLED FROM THE RIGHT INTERNAL JUGULAR CENTRAL LINE. THE BAXTER ONE-LINK NEEDLE FREE CONNECTOR WAS FOUND TO BE SPLIT, CLOUDY, MIS-SHAPEN AND LEAKING. THE CAP WAS REPLACED AND THE BLEEDING STOPPED. ANOTHER CONNECTOR WAS EXPOSED TO BE COLLODION REMOVER IN-VITRO AND REACTED THE SAME WAY. REASON FOR USE: TO REMOVE EEG LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305471 MAVIDON COLLODION REMOVER 128 OZ MAVIDON COLLODION REMOVER 128 OZ GYB MAVIDON
    305472 ONE-LINK NEEDLE-FREE IV CONNECTOR ONE-LINK NEEDLE-FREE IV CONNECTOR FPA BAXTER 7N8399 07-36-71-510

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention