BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM

    MDR report key: 7057374 · Received November 24, 2017

    Report

    Report Number
    MW5073540
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    MALEM
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I AM A PARENT FROM (B)(6). I BOUGHT A BRAND NEW MALEM ALARM ON A TRIP TO USA AND GAVE IT TO MY SON TO USE TO STOP HIS ENURESIS. THE BEDWETTING ALARM IS DEFECTIVE STRAIGHT OUT OF THE BOX. AS SOON AS BATTERIES ARE PUT IN THE SYSTEM, THE ALARM STARTS TO GET HOT, VERY HOT. MY SON WAS SO SCARED TO USE IT AND WE TOLD HIM THAT IT WOULD GET A LITTLE HOT AS WE HAD HEAT ON FOR THE WINTER AS WELL. BUT UNFORTUNATELY, THE COMPLETE ALARM SYSTEM WENT HAYWIRE AND GOT VERY VERY HOT. MY BOY HAD TO PULL IT OFF AND WE SAW BATTERY LEAK ON HIS NIGHTDRESS. THE ALARM WAS HOT LIKE A METAL ROD. THIS COULD BE VERY DANGEROUS IF IT WAS NOT REMOVED ON TIME AND COULD HAVE CAUSED PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836897 MALEM MALEM KPN MALEM M04

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention