BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ALARM

    MDR report key: 8793410 · Received July 15, 2019

    Report

    Report Number
    MW5088128
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PEDIATRICIAN RECOMMENDED THAT MY SON USE A BEDWETTING ALARM TO TREAT HIS WETTING PROBLEM. THE ALARM WE FOUND ON THE INTERNET WAS MALEM AND PURCHASED IT IN NEW CONDITION FROM THE MFR'S WEBSITE. THE ALARM HAS BEEN USED FOR 3 NIGHTS AND EACH NIGHT, MY SON DID NOT WET THE BED, BUT HE HAS COMPLAINED OF GETTING SHOCKS. HE SWEATS A LOT AND THIS CAUSES THE ALARM TO VIBRATE (I HAVE IT ON VIBRATE SETTING). IT DOES VIBRATE AND HE GETS SHOCKS. HE DID NOT TELL ME THE FIRST THREE NIGHTS, BUT WHEN I WENT TO ATTACH IT ON HIM, HE WAS SCARED AND REFUSED TO WEAR. HE WAS AWAKE ALL NIGHT, AFRAID THAT IF HE WETS, HE WILL GET ANOTHER SHOCK. I PUT THE ALARM AND SENSOR IN A DAMP CLOTH AND TOUCHED IT AS WELL AND I CAN FEEL A TINGLING ON MY FINGERS. THIS IS UNSAFE TO OPERATE ON HIM. THIS IS SHOCK THERAPY, NOT WHAT WE EXPECTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583966 MALEM ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. ULTIMATE ALARM LIGHT BLUE COLOR

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other| R