BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 5018219 · Received August 15, 2015

    Report

    Report Number
    MW5055542
    Event Type
    Injury
    Date Received
    August 15, 2015
    Report Date
    August 15, 2015
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT I AM COMPLAINING ABOUT IS A BEDWETTING ALARM, BUT IS MARKETED AS A POTTY TRAINING PRODUCT BY THE MFR, A (B)(6) COMPANY. THE PRODUCT HAS SMALL PARTS (BATTERY DOOR) WHICH CAN FALL OFF AND CAN BE A CHOKING HAZARD FOR CHILDREN. THERE HAVE BEEN A NUMBER OF REPORTS WHERE CHILDREN HAVE SWALLOWED THE BATTERY DOOR AND THIS HAS RESULTED IN CHOKING. MANY CHILDREN HAVE BEEN RUSHED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540604 MALEM BEDWETTING ALARM MALEM BEDWETTING ALARM KPN MALEM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening| R