BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUPPY DOG ELECTRODE

    MDR report key: 1040907 · Received May 9, 2008

    Report

    Report Number
    MW5006824
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 9, 2008
    Manufacturer
    TYCO HEALTHCARE GROUP LP
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FLUID FILLED BLISTERS NOTED ON RIGHT CHEST UNDER EKG ELECTRODE -KENDALL PUPPY DOG 5 LEAD PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODE-. ELECTRODES PLACED ON CHILD IN 2008 FOR OPEN HEART SURGERY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC MONITORING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUPPY DOG ELECTRODE PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODE DRX TYCO HEALTHCARE GROUP LP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Disability