BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE BEDWETTING ALARM

    MDR report key: 7078631 · Received December 1, 2017

    Report

    Report Number
    MW5073681
    Event Type
    Injury
    Date Received
    December 1, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I GIFTED A MALEM ULTIMATE BEDWETTING ALARM TO A FRIEND OF MINE. LEAST DID I KNOW THAT THE ALARM OVERHEATED AND HER CHILD GOT BURNT BY USING IT AND HAD TO BE RUSHED TO THE HOSPITAL FOR TREATMENT. THIS IS THE WORST GIFT I HAVE EVER GIVEN ANYONE AND I FEEL GUILTY HAVING SENT THIS ALARM TO HER. I HAVE CONTACTED THE COMPANY BUT NO ONE RESPONDS BACK. THIS PRODUCT IS DANGEROUS AND SHOULD BE RECALLED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853866 MALEM ULTIMATE BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R