BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 7063309 · Received November 28, 2017

    Report

    Report Number
    MW5073572
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 23, 2017
    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

    MY (B)(6) DAUGHTER SWALLOWED THE MALEM BEDWETTING ALARM BATTERY DOOR. I WAS LUCKILY TO HAVE REMOVED IT ON TIME; HOWEVER, SHE SUFFERED CUTS ON HER TONGUE. I AM GLAD SHE DIDN'T SWALLOW IT. PRODUCT IS MISSING SUCH INFO ON ITS PACKAGING. I REQUEST THE FDA TO RECALL THIS PRODUCT FROM THE MARKET. FYI, I PURCHASED THIS PRODUCT FROM THE BEDWETTING STORE. THE MFR OF THE ALARM IS MALEM MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841955 MALEM BEDWETTING ALARM MALEM BEDWETTING ALARM KPN MALEM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention