BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE BEDWETTING ALARM

    MDR report key: 8632045 · Received May 21, 2019

    Report

    Report Number
    MW5086812
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY WIFE SET UP THE ENURESIS ALARM FOR HELPING MY DAUGHTER OVERCOME BEDWETTING, BUT THE DEVICE HAS DONE DAMAGE TO HIM INSTEAD OF HELPING HIM. THE ALARM LIKELY SHORT CIRCUITED AT NIGHT WHEN SHE WAS USING IT AND ASLEEP. AS A RESULT, THE ALARM BURNT HER SKIN ON CONTACT AND SHE WAS IN A LOT OF PAIN. THE AREA IS ABOUT 1 SQ INCH WHERE THE ALARM WAS TOUCHING HER AND IT WAS RED WHEN WE CHECKED. IT WAS NOT VERY SERIOUS, BUT ENOUGH FOR US TO REPORT THIS TO THE DR'S OFFICE AND TO THE FDA. WE HAVE DISCONTINUED THE USE OF THE PRODUCT AS IF APPEARS TO BE DANGEROUS. THE ONLY WAY WE COULD COOL IT DOWN WAS TO REMOVE BATTERIES. OTHER THAN THAT, IT'S A HOT UNSTABLE DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423679 MALEM ULTIMATE BEDWETTING ALARM ALARM CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M043

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention