BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM

    MDR report key: 8074490 · Received November 14, 2018

    Report

    Report Number
    MW5081297
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MALEM MEDICAL LTD
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUR CLINIC TREATED A (B)(6) BOY WHO HAS BEEN BURNT FROM AN ENURESIS ALARM. THE CHILD IS STABLE BUT HAS BIG BRUISES ON HIS NECK WHERE THE ALARM WAS TOUCHING HIS SKIN. THIS IS THE RESULT OF AN ELECTRICAL MALFUNCTION IN THE ALARM. THE DEVICE SHORT CIRCUITED AND CAUSED BATTERIES TO LEAK. THE BATTERIES SPILLED ONTO THE CHILD'S BODY. A COMBINATION OF HOT PLASTIC AND BATTERY SCARRED THE CHILD'S SKIN WHILE HE WAS ASLEEP. WE HAVE RECOMMENDED THAT THE PARENTS DISCONTINUE USING THE ALARM. WE HAVE RETURNED THE ALARM BACK TO THE PARENTS. THE ALARM HOUSING HAS BENT INWARDS FROM EXCESS HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908245 MALEM "ALARM, CONDITIONED RESPONSE ENURESIS" KPN MALEM MEDICAL LTD M04B

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization