BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 6993394 · Received November 1, 2017

    Report

    Report Number
    MW5073060
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 28, 2017
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    TODAY WAS THE THIRD NIGHT THAT THE MALEM ALARM WAS USED. MY SON WAS ASLEEP IN THE EARLY EVENING AND THE MALEM ALARM ONCE AGAIN OVERHEATED. THE BACK OF THIS ALARM GOT SO HOT THAT IT FELT LIKE A HOT PLATE. THE BACK HAS ALREADY DEFORMED FROM THE HEAT AND MY SON CAN NO LONGER WEAR IT. IT FEELS LIKE SOMEONE PLACED A HOT IRON ROD ON HIS NECK. HE HAS A SMALL RED BURN MARK ON HIS NECK. THIS IS ONLY THE THIRD DAY OF USE. NOT A SAFE PRODUCT FOR CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774202 MALEM BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention