BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE SELECTABLE ENURESIS ALARM

    MDR report key: 8186524 · Received December 19, 2018

    Report

    Report Number
    MW5082376
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 18, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ABOUT TWO WEEKS AGO, PARENTS HAD REPORTED THAT THEIR CHILD WAS BURNT BY THE NOCTURNAL ENURESIS ALARM. OUR CLINIC ROUTINELY RECOMMENDS ALARMS TO PARENTS AND THEY PURCHASE WHAT THEY LIKE. IN THIS PARTICULAR CASE, PARENTS ORDERED A MALEM ENURESIS ALARM. THE NEW DEVICE HAS MALFUNCTIONED AND WHEN THE CHILD WAS ASLEEP, THE ALARM "SHORT" OUT FROM THE INSIDE AND OVERHEATED. THIS CAUSED THE BATTERIES TO EXPLODE INSIDE THE DEVICE AND LEAK ON THE CHILD¿S CLOTHING. IN ADDITION, THERE WAS EXCESS HEAT GENERATED BY THE DEVICE WHICH BURNT THE CHILD¿S NECK. ALTHOUGH THE BURNS WERE MINOR AND ATTRIBUTED MORE TO STINGING, THEY ARE IMPORTANT TO REPORT. THE BURNS HAVE CAUSED SMALL BLISTERS ON THE CHILD¿S NECK AND CURRENTLY SHE IS UNDERGOING TREATMENT FOR BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017901 MALEM ULTIMATE SELECTABLE ENURESIS ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| O| R