BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE BEDWETTING ALARM

    MDR report key: 6964344 · Received October 20, 2017

    Report

    Report Number
    MW5072844
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 18, 2017
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    I AM SHOCKED TO SEE THAT THE FDA IS ALLOWING DANGEROUS PRODUCTS TO BE SOLD FOR CHILDREN HERE IN THE US MARKET. MY (B)(6) SON WAS BADLY HURT WITH THE MALEM BEDWETTING ALARM WHEN WE USED IT ON TO STOP HIS BEDWETTING. THE QUALITY OF THE ALARM IS SO POOR THAT THE BACK OF THE ALARM MELTED AND BURNT MY SON'S NECK. WE RUSHED TO THE HOSPITAL TO TREAT HIM. I PURCHASED THIS MALEM ULTIMATE ALARM FROM (B)(6). THIS IS AN EXTREMELY UNSAFE PRODUCT AND MUST BE PULLED OFF THE MARKET. I ALSO REQUEST THE FDA TO INSPECT THE MALEM MEDICAL (WHO IS THE MANUFACTURER OF THE PRODUCT) FOR QUALITY AND SAFETY. THE MANUFACTURER RESIDES IN THE (B)(4) (A SIMPLE SEARCH ON (B)(6) WILL GET YOU THE MANUFACTURERS DETAILS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743958 MALEM ULTIMATE BEDWETTING ALARM BEDWETTING ALARM KPN MALEM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization