BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 8821835 · Received July 23, 2019

    Report

    Report Number
    MW5088305
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A MALEM BEDWETTING ALARM FOR MY SON AND ON THE FIRST USE IT BURNT HIM. HE IS NOW SEEKING MEDICAL HELP. EVERYTHING WAS CORRECTLY DONE FROM OUR SIDE AS WE FOLLOWED INSTRUCTIONS STATED IN THE MANUAL, HOWEVER THE PRODUCT IS FAULTY. MY (B)(6) SON IS SUFFERING FOR NO FAULT OF HIS. I WOULD LIKE THE FDA LOOK INTO THIS SOON. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609420 MALEM BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention