BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 7973357 · Received October 16, 2018

    Report

    Report Number
    MW5080581
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 14, 2018
    Report Date
    October 14, 2018
    Manufacturer
    MALEM MEDICAL LTD
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    FOR NO APPARENT REASON AT ALL, THE ENURESIS ALARM IS GETTING HOT. YOU PUT IN THE BATTERIES AND THE SENSOR, AND IT'S GETTING HOT LIKE BOILING WATER. SOMETHING WAS SERIOUSLY WRONG WITH THE DEVICE. MY SON WAS WEARING IT IN HIS AFTERNOON NAP AND COMPLAINED IF STINGING. HAD TO REMOVE BATTERIES TO PREVENT OVERHEATING AND SKIN BURN. NOT SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813029 MALEM BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD M05

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention