BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL TYCO HEALTHCARE

    MDR report key: 2268923 · Received September 22, 2011

    Report

    Report Number
    MW5022381
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 22, 2011
    Manufacturer
    KENDALL TYCO HEALTHCARE
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON TWO PTS, WHEN TELEMETRY PATCHES TAKEN OFF, UNDERNEATH THE PATCHES THE PT'S SKIN WAS BLISTERY AND PUS DRAINAGE COMING FROM OPEN AREAS UNDERNEATH THE PATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL TYCO HEALTHCARE TELEMETRY PATCHES/CONDUCTIVE ADHESIVE ELECTRODES MLN KENDALL TYCO HEALTHCARE 114406

    Patients

    Seq Age Sex Outcome Treatment
    1