BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ENURESIS ALARM

    MDR report key: 6986650 · Received October 30, 2017

    Report

    Report Number
    MW5073019
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 21, 2017
    Report Date
    October 26, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ALL I DID WAS INSERT BATTERIES IN THE ALARM FOR MY DAUGHTER AND SET IT ON THE DESK WHILE WE HAD DINNER. WHEN I GOT BACK 45 MINUTES LATER, BATTERIES HAD LEAKED FROM THE ALARM ON TO THE DESK AND DAMAGED THE DESK. THE PLASTIC HAD ALSO PARTIALLY MELTED FROM THE BATTERY LEAK HEAT. TO THINK OF WHAT WOULD HAVE HAPPENED IF MY SON WERE TO WEAR IT AT NIGHT! I CAN'T EVEN IMAGINE HOW DANGEROUS THIS WOULD BE. I AM HAPPY THAT WE DID NOT USE IT. THE RESULTS WOULD BE DEVASTATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766066 MALEM ENURESIS ALARM MALEM ENURESIS ALARM KPN MALEM MEDICAL M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention