BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 7984249 · Received October 18, 2018

    Report

    Report Number
    MW5080684
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    SO DISAPPOINTED. MY SON WHO IS (B)(6) AND HAS HAD BEDWETTING PROBLEM AND WE TRIED THE MALEM BEDWETTING ALARM THAT WORKED GOOD FOR THREE DAYS AND ON THE 4TH ALL OF A SUDDEN, I COULD HEAR MY SON YELLING AND CALLED ME TO HIS ROOM AND TOLD ME TO TOUCH THE ALARM. IT WAS LIKE BOILING HOT WATER. HE HAD A VISIBLE RED PATCH ON HIS NECK. I HAD TO GIVE HIM FIRST AID TREATMENT. I NEVER EXPECTED TO ENCOUNTER SUCH DANGEROUS PRODUCTS FOR CHILDREN IN THE MARKET. THIS PRODUCT SHOULD BE REMOVED FROM THE CONSUMER MARKET IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817217 MALEM BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention