BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 8865842 · Received August 5, 2019

    Report

    Report Number
    MW5088803
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 30, 2019
    Report Date
    August 1, 2019
    Manufacturer
    MALEM MEDICAL, LTD
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A MALEM ALARM FROM THE (B)(6) STORE. THE FIRST TIME WE USED IT, THE ALARM OVERHEATED AND BURNT MY (B)(6) YEAR OLD SON. THE FDA NEEDS TO LOOK INTO THIS ISSUE ASAP. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656908 MALEM BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL, LTD M04

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention