BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ENURESIS ALARM

    MDR report key: 6185982 · Received December 16, 2016

    Report

    Report Number
    MW5066779
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 16, 2016
    Manufacturer
    MALEM MEDICAL (BEDWETTING STORE)
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I PRESCRIBED A NOCTURNAL ENURESIS ALARM FOR A (B)(6) FEMALE PT 3 WEEKS AGO. THE PARENT PURCHASED AND USED THE SAME. ON THE SECOND NIGHT, I WAS INFORMED THAT THE CHILD HAS TO BE ADMITTED TO THE EMERGENCY ROOM. THE NOCTURNAL ENURESIS ALARM HAD EXPLODED AND DAMAGED THE SUBJECTS SKIN. THE ALARM HAD OVER HEATED, MALFUNCTIONED AND MELTED ON THE CHILD'S CHEST CAUSING FIRST DEGREE BURNS AND PERMANENT SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834368 MALEM ENURESIS ALARM MALEM BEDWETING ALARM KPN MALEM MEDICAL (BEDWETTING STORE) MO4S2

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R