BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE SELECTABLE BEDWETTING ALARM

    MDR report key: 8014186 · Received October 26, 2018

    Report

    Report Number
    MW5080866
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    October 16, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A MEDICAL DEVICE WE WERE USING TO STOP NIGHT TIME BEDWETTING HAS MALFUNCTIONED AFTER JUST 2 NIGHTS OF USE. THE ALARM HAS OVERHEATED AND SHORT THE BATTERIES INSIDE THE CASE. THIS HAS CAUSED THE BACK TO HEAT UP AND BURN MY SON'S NECK. THE BATTERIES LEAKED ON HIS CLOTHES AND THE COMBINATION HAS CAUSED SEVERE SKIN IRRITATION. HE HAS BEEN RECEIVING MEDICAL TREATMENT FOR THIS. THE ALARM WAS NEW AND USED EXACTLY AS EXPLAINED IN THE USER MANUAL. DEFECTIVE AND DANGEROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851367 MALEM ULTIMATE SELECTABLE BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. RED COLOR

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention