BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM

    MDR report key: 8023502 · Received October 30, 2018

    Report

    Report Number
    MW5080932
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 25, 2018
    Report Date
    October 26, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON IS USING A MALEM ALARM WHICH IS GETTING VERY HOT. WE HAVE DISCONTINUED USE. THERE IS A TECHNICAL ISSUE WITH THE ALARM THAT CAUSES IT TO BECOME HOT. DEFECTIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861251 MALEM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention