BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ALARM

    MDR report key: 7973358 · Received October 16, 2018

    Report

    Report Number
    MW5080582
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 13, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUR CLINIC HAS TREATED AN (B)(6) BOY WHOSE NECK CAME IN CONTACT WITH A MALFUNCTIONED MALEM BEDWETTING ALARM. THE BOY'S PARENTS HAD SET UP THE ALARM WHILE THE CHILD SLEPT AT NIGHT. THEY HAVE SAID THAT THE ALARM EXPLODED AT NIGHT FROM HEAT AND BURNT THE BOY'S NECK. THE ALARM CLEARLY SHOWED SIGNS OF OVERHEATING, BATTERY LEAK AND A SHORT CIRCUIT IN THE ELECTRICAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813030 MALEM ALARM ENURESIS ALARM / ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other