BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM AKA MALEM ENURESIS ALARM

    MDR report key: 6672766 · Received June 26, 2017

    Report

    Report Number
    MW5070659
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    June 24, 2017
    Report Date
    June 26, 2017
    Manufacturer
    MALEM
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE MALEM BEDWETTING ALARM WHICH I PURCHASED FROM (B)(6) OVERHEATED AND BURNT MY SON. THIS WAS THE FIRST NIGHT WE EVER USED THE ALARM AND FOLLOWED AS MENTIONED IN THE MANUAL. MY SON WAS HURT AND WE HAD TO RUSH HIM TO A DOCTOR. MALEM IS AN INFERIOR QUALITY PRODUCT WHICH NEEDS TO BE REMOVED FROM THE MARKET. "IS THERE ANY BECAUSE THEY CLAIM TO HAVE BEEN SELLING ALARMS SINCE 1970S."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447599 MALEM BEDWETTING ALARM AKA MALEM ENURESIS ALARM MALEM BEDWETTING ALARM AKA MALEM ENURESIS ALARM KPN MALEM

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention