BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ALARM

    MDR report key: 8624021 · Received May 17, 2019

    Report

    Report Number
    MW5086745
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 15, 2019
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ALARM EXPLODED 30 MINS INTO USE AND HURT SON ((B)(6) Y/O) IN HIS NECK. THE CAUSE OF THE EXPLOSION WAS DEFECT IN THE ALARM. BATTERIES ALSO LEAKED OUT OF THE DEVICE AND SPREAD ON HIS SKIN CAUSING ALLERGIC REACTION. COMBINATION OF HEAT FROM ALARM AND BATTERY LEAK BURNT HIM AND HE HAD TO BE TAKEN TO THE CLINIC FOR TREATMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411908 MALEM ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M0-43

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR