BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENURESIS ALARM

    MDR report key: 8028095 · Received October 31, 2018

    Report

    Report Number
    MW5080974
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 26, 2018
    Report Date
    October 29, 2018
    Manufacturer
    MALEM MEDICAL LTD
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON FRIDAY, WE TREATED A (B)(6) BOY WHO WAS INJURED BY THE USE OF AN ENURESIS ALARM. THE NEW MALEM ALARM OVERHEATED AND BURNT THE CHILD AT NIGHT WHEN HE WAS SLEEPING. PARENTS BROUGHT IN THE CHILD TO OUR CLINIC AND WE TREATED HIM FOR MINOR BURNS. THE MALEM ALARM HAS MALFUNCTIONED CAUSING ACCESS HEAT AND BURNING THE CHILD'S NECK. THERE APPEARS NOTHING WRONG WITH HOW THE ALARM WAS USED OR OPERATED. THE MALFUNCTION IS A RESULT OF THE MALEM ALARM. IN ADDITION TO HEAT, THE ALARM ALSO CAUSED BATTERIES TO LEAK. WE HAVE RETURNED THE ALARM TO THE PT AND RESPECT THEIR PRIVACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862918 ENURESIS ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other