BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM

    MDR report key: 7956070 · Received October 10, 2018

    Report

    Report Number
    MW5080453
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 8, 2018
    Manufacturer
    MALEM MEDICAL LTD
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), A FAMILY BROUGHT IN THEIR CHILD AT 10:30 PM TO OUR CLINIC. THE CHILD HAD BEEN INJURED FROM THE USE OF A MALEM BEDWETTING ALARM. PARENTS HAD USED A NEW ALARM WHICH WAS PURCHASED ONLINE FROM (B)(6) WEBSITE. THE ALARM WAS SHIPPED AND ARRIVED TO PARENTS A DAY BEFORE THE INCIDENT. THE PARENTS SAID THAT THEY SET UP THE MALEM ALARM AS WAS INSTRUCTED IN THE USER MANUAL AND THE BOY WENT TO SLEEP. THE BOY COMPLAINED OF AN EXTREMELY HOT OBJECT TOUCHING HIS NECK AND THEN PARENTS REALIZED AND REMOVED THE ALARM. BY THEN, THERE WAS A SKIN BURN ON THE BOY'S NECK. IN OUR CLINIC, WE TREATED THE BOY AND LET HIM GO. HE WAS DIAGNOSED WITH SKIN BURNS. THE ALARM HAS DEFORMED FROM HEAT THAT WAS PRODUCED BY THE MALEM ALARM AND THERE WERE INDICATIONS OF BATTERY LEAK AND DISCHARGE ON THE ALARM. THE ALARM BOTTOM WHICH IS MADE OF PLASTIC HAS PARTIALLY MELTED FROM HEAT. THE BATTERY LEAK ALSO WAS ON THE BOY'S NECK AND HE HAS SUFFERED FROM ALLERGIC REACTION. THE CLINIC HAS RETURNED THE ALARM TO THE PARENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795497 MALEM BEDWETTING ALARM KPN MALEM MEDICAL LTD M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization