BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMATE BEDWETTING ALARM

    MDR report key: 8101934 · Received November 23, 2018

    Report

    Report Number
    MW5081594
    Event Type
    Injury
    Date Received
    November 23, 2018
    Report Date
    November 21, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE BEDWETTING ALARM PRESCRIBED BY THE DR HAS HAD AN ADVERSE REACTION AND INJURED MY DAUGHTER. SHE WAS SLEEPING AT NIGHT WEARING THE ALARM AND 4 MINS INTO HER SLEEP, SHE CRIED LOUDLY AND COMPLAINED OF BURNS. I THOUGHT IT IS JUST NOT POSSIBLE SINCE THIS IS A BATTERY OPERATED PRODUCT, BUT I WAS WRONG. SHE HAD INDEED BEEN BURNT AT THE POINT WHERE THE ALARM TOUCHED HER SKIN. SHE WAS HOLDING THE T-SHIRT AWAY TO PREVENT MORE HARM. I ALSO NOTICED THAT THE ALARM WAS SO HOT THAT THE BACK DOOR HAD DEFORMED FROM HEAT. OVERALL NOT SAFE AND PRETTY SCARED THAT THIS HAPPENED. I WAS ABLE TO TREAT HER ON TIME AT HOME, BUT FOUND IT USEFUL TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938643 ULTIMATE BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M05

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other