BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRY EASY BEDWETTING ALARM

    MDR report key: 9451556 · Received December 10, 2019

    Report

    Report Number
    MW5091577
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 7, 2019
    Manufacturer
    MARVELWORKS LTD.
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WE USED THE DRY EASY BEDWETTING ALARM TO CURE OUR SONS NIGHTMARE BEDWETTING PROBLEM. THE RESULTS WERE NOT ACHIEVED IN EVEN 4 MONTHS. WE PURCHASED MALEM ULTIMATE PRO BEDWETTING ALARM FROM (B)(6) WEBSITE. ALARM HAS ELECTRICAL ISSUES. ALL WE DID WAS INSERT BATTERIES AND CONNECT SENSOR AND THERE WAS SMOKE COMING FROM THE TOP OF THE DEVICE. IT WAS LIKE THE ELECTRONICS WERE ON FIRE, YOU COULD SEE FUMES AND SMELL PLASTIC BURNING. AFRAID FOR SAFETY. I REMOVED THE BATTERIES. NO, THE BATTERIES WERE INSERTED CORRECTLY. THE ISSUE IS WITH THE NEW DEVICE. WHAT IS SCARY IS THAT IT IS A NEW DEVICE I REACHED OUT TO (B)(6) AND MALEM 3 TIMES BUT NO RESPONSE FROM THEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243194 DRY EASY BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MARVELWORKS LTD.
    1243195 ULTIMATE PRO BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention