BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 6993372 · Received November 1, 2017

    Report

    Report Number
    MW5073058
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 29, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE MALEM BEDWETTING ALARM IS AN INFERIOR AND POORLY DESIGNED PRODUCT, THAT GETS HOT LIKE AN IRON. WE USED THIS PRODUCT ON MY SON FOR JUST 4 HOURS AND THE ALARM BURNT HIM ON HIS NECK. THIS PRODUCT HAS SOME SERIOUS PROBLEMS AND MUST BE RECALLED FROM THE US MARKET. MY SON RECEIVED TREATMENT FROM OUR FAMILY PHYSICIAN BUT THE BURN MARKS STILL PERSIST. I BOUGHT THIS ALARM FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774209 MALEM BEDWETTING ALARM BEDWETTING ALARM KPN MALEM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention