BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 6180390 · Received December 14, 2016

    Report

    Report Number
    MW5066712
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 14, 2016
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A NOCTURNAL ENURESIS ALARM FOR MY (B)(6) BOY FROM THE BEDWETTING STORE WEBSITE - (B)(6). I PURCHASED A MALEM BEDWETTING ALARM FROM THEM YOU CAN SEE THE PRODUCT AT (B)(6). I PUT IN BATTERIES AND SHOWED MY SON HOW TO USE IT. I PUT THE ALARM AND CLIP SENSOR ON HIM AND WENT TO BED. AT ABOUT 3:30 AM IN THE MORNING, HE SCREAMED IN PAIN AND RAN TO ME. THE MALEM ALARM WAS ON FIRE. THE PLASTIC HOUSING HAS STARTED TO MELT AND THE UNIT WAS SO HOT THAT IT HURT MY SON. I AM FRUSTRATED AND DEVASTATED FROM THIS. I TOOK MY SON TO THE HOSPITAL EMERGENCY ROOM AND TREATED HIM FOR BURNS. THIS IS A HORRIBLE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823586 MALEM BEDWETTING ALARM MALEM BEDWETTING ALARM KPN MALEM MEDICAL MO4S2

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R