BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMATE BEDWETTING ALARM

    MDR report key: 8094733 · Received November 20, 2018

    Report

    Report Number
    MW5081527
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    November 16, 2018
    Report Date
    November 19, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE BEDWETTING ALARM HAS AN ELECTRICAL ISSUE. IT SHORT-CIRCUITED IN THE MIDDLE OF THE NIGHT WHEN MY SON WAS SLEEPING AND BURNT HIM IN THE NECK. WE TOOK HIM TO THE ER FOR TREATMENT. THIS IS A SMALL PRODUCT, BUT A DANGEROUS ONE. MY CALLS TO THE COMPANY HAVE NOT BEEN ANSWERED. THEY HAVE IGNORED THE INCIDENT. MY SON IS NOW AFRAID TO USE A BEDWETTING ALARM AND HIS NIGHTTIME BEDWETTING IS ONLY GETTING WORSE. WE HAVE HAD TO TAKE HIM FREQUENTLY TO THE PEDIATRICIAN FOR FOLLOWUP FROM THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932900 ULTIMATE BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR