BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM

    MDR report key: 6995727 · Received November 2, 2017

    Report

    Report Number
    MW5073076
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 30, 2017
    Report Date
    October 31, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OUR MALEM BEDWETTING ALARM USES 2 AAA BATTERIES. WE INSERTED BATTERIES IN THE ALARM UNIT AND SET IT UP AT NIGHT. MY DAUGHTER WAS WEARING THE ALARM AT 9PM PST AND SHE WENT TO BED. ABOUT 30 MINUTES AGO AT 11:30PM, THE ALARM STARTED ACTING UP AND BATTERIES LEAKED OUT OF THE ALARM ONTO MY DAUGHTER'S CLOTHING. I WAS QUICK TO NOTICE IT AS WE SLEEP IN THE SAME ROOM AND QUICKLY PULLED THE ALARM OFF FROM HER. THE BATTERY CONTINUED TO LEAK OUT FOR NEXT 2-3 MINUTES. THE ALARM HAS HEATED SIGNIFICANTLY. IT IS NOT A BATTERY DEFECT, BUT AN ALARM ISSUE. EITHER THE ALARM IS SHORTING THE BATTERIES OUT OR THE ALARM HAS SOME OTHER MECHANICS THAT IS FAILING. EITHER WAY, THIS IS A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776253 MALEM MALEM KPN MALEM MEDICAL M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention