BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALEM BED-WETTING ENURESIS ALARM

    MDR report key: 7112035 · Received December 12, 2017

    Report

    Report Number
    MW5073923
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 10, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AS SOON AS I PUT BATTERIES INTO THE ALARM, WITHIN 20 MINUTES OR SO, THE ALARM EXPLODED. THE BATTERIES LEAKED OUT AND BACK BLUE COVER MELTED FROM THE HEAT. THE ALARM WAS SO HOT THAT I BURNT MY FINGER TOUCHING IT. THIS WAS GOING TO BE PLACED ON MY SON'S NECK! VERY DANGEROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886432 MALEM BED-WETTING ENURESIS ALARM MALEM BED-WETTING ENURESIS ALARM KPN MALEM MEDICAL M04

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other