BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ENURESIS ALARM

    MDR report key: 6940162 · Received October 11, 2017

    Report

    Report Number
    MW5072671
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 5, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTING ADVERSE EVENT WITH AN ENURESIS ALARM. THE CHILD WAS BURNT AND BRUISED WITH THE MALEM ENURESIS ALARM. SOURCE OF BURNS WERE CHEMICAL BURNS FROM BATTERY LEAK. THE ALARM HAS MALFUNCTIONED AND CAUSED BATTERIES TO LEAK INTO CLOTHING. CHILD TRIED TO REMOVE THE ALARM AND IN THE PROCESS BATTERY ACID HAS LEAKED ON TO THE CHILD'S HANDS. CHILD ACCIDENTLY PLACED HANDS IN MOUTH AND SWALLOWED BATTERY ACID. THE CHILD HAS MINOR BURNS FROM ALARM AND BRUISES ON NECK AREA. THE CHILD ALSO HAS BEEN TREATED FOR ACCIDENTAL BATTERY ACID CONSUMPTION. CHILD WAS ADMITTED TO ER AND DISCHARGED AFTER OBSERVATION THE NEXT DAY. CURRENTLY THE CHILD IS VISITING DOCTOR FOR TREATMENT WITH BLISTERS AND BURNS. THE ENURESIS ALARM IS IN OUR POSSESSION AND IT APPEARS THAT THE CAUSE OF MALFUNCTION WAS THE ALARM ITSELF. THE HEATING AND BATTERY LEAK ALSO CAUSED THE ALARM BATTERY DOOR TO BEND INWARD AND MELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719943 MALEM ENURESIS ALARM MALEM ENURESIS ALARM KPN MALEM MEDICAL M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening