BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEDWETTING ALARM

    MDR report key: 7929781 · Received October 2, 2018

    Report

    Report Number
    MW5080289
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    September 25, 2018
    Report Date
    September 30, 2018
    Manufacturer
    MALEM MEDICAL LTD
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I HAVE FOUND A DEFECT AND PROBLEM WITH MY DAUGHTER'S MALEM ENURESIS ALARM. THIS DEVICE, WHICH IS BRAND NEW IS OVERHEATING WHEN THE MOISTURE SENSOR IS CONNECTED TO IT. THE ENURESIS ALARM STARTS MAKING A STRANGE SOUND AND THE BACKSIDE BECOMES HOT. IT IS NOT POSSIBLE FOR MY DAUGHTER TO WEAR THIS ALARM AS THE TEMPERATURE WILL BURN HER. I HAVE EXPERIENCED WITH ENURESIS ALARMS, BUT THIS IS NOT HOW THEY OPERATE. THIS IS CLEARLY A MFG DEFECT OR A CRITICAL DESIGN FLAW WHICH CAN BURN SKIN ON CONTACT WITHIN A FEW MINUTES. THE ENURESIS ALARM IS NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768507 BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD M04

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention