BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEDWETTING ALARM FOR CHILDREN

    MDR report key: 8180307 · Received December 18, 2018

    Report

    Report Number
    MW5082266
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    December 14, 2018
    Report Date
    December 15, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER WAS SLEEPING AS USUAL WITH HER NIGHTTIME WETTING ALARM. SHE COMPLAINED THAT IT WAS HOT AND WHEN I CHECKED, IT WAS INDEED HOT. I REMOVED IT AND KEPT IT ON THE SIDE. AFTER 15 MINS, IT WAS EXTREMELY HOT. I COULD HEAR A VIBRATION IN THE ALARM PORTION. WHEN THE SENSOR IS REMOVED, THE VIBRATION STOPPED AND IT STARTED TO COOL DOWN, BUT WITH THE SENSOR CONNECTED, IT'S HOT. I WORRY THAT IT WOULD GET HOT TO A POINT WHERE IT WOULD JUST BURN MY DAUGHTER IN HER SLEEP. DISCONTINUED USE AFTER 3 NIGHTS. BAD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014938 BEDWETTING ALARM FOR CHILDREN ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention