BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 6194081 · Received December 20, 2016

    Report

    Report Number
    MW5066829
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PURCHASED MALEM ALARM FROM (B)(6) AFTER READING ADVERTISEMENT THAT SAID IT CAN CURE BEDWETTING 100 PERCENT. SUPER EXCITED TO USE IT. PUT IT ON MY DAUGHTER AT 8:30PM BEFORE HER BEDTIME AND AT 9:15PM, SHE CAME DOWN IN TEARS THAT SHE THREW THE MALEM AS IT BURNT HER. MY HUSBAND AND I WENT BACK TO THE ROOM AND THE MALEM ALARM WAS SUPER HOT. THE BACK BATTERY DOOR HAD PARTLY MELTED AND MY DAUGHTER'S NECK WAS RED FROM THE BURN. HOW DOES THIS COMPANY MAKE A PRODUCT THAT IS SO DANGEROUS AND ADVERTISE AS A 100 PERCENT SAFE CURE FOR BEDWETTING. I FEEL BETRAYED AS THIS WAS SUPPOSED TO CURE HER BEDWETTING. WE USED NEOSPORIN AND TOOK HER TO THE DOCTORS OFFICE IN THE MORNING. HE TOLD US TO CONTACT FDA AND REPORT THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840503 MALEM BEDWETTING ALARM BEDWETTING ALARM KPN MALEM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR