BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE RECORDABLE BEDWETTING ALARM

    MDR report key: 7960237 · Received October 11, 2018

    Report

    Report Number
    MW5080510
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WE ARE VERY DISAPPOINTED WITH THE QUALITY OF THE MALEM BEDWETTING ALARM WHICH WE RECENTLY PURCHASED. THE ALARM WORKED FINE THE FIRST NIGHT, BUT LAST NIGHT, IT WAS BEHAVING VERY ERRATIC. WHEN MY DAUGHTER WAS INSERTING THE SENSOR INSIDE THE ALARM, IT WAS MAKING A RATTLE SOUND AND STARTING TO GET HOT. AT FIRST, WE WERE NOT SURE WHY THE ALARM WAS RATTLING, SO WE TOOK OUT BATTERIES AND REPLACED THEM. SAME THING HAPPENED. AFTER 30 MINUTES THE RATTLING BECAME LOUDER BUT THE ALARM WAS VERY HOT. DANGEROUSLY HOT FOR MY DAUGHTER. THERE IS SOMETHING SERIOUSLY WRONG WITH THE DEVICE THAT IS CAUSING IT TO RATTLE AND OVERHEAT. GOOD THING SHE WASN'T ASLEEP OR WEARING IT WHEN SLEEPING OR IT COULD HAVE BEEN EXTREMELY DANGEROUS AS THIS IS PLACED NEAR HER NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799383 MALEM ULTIMATE RECORDABLE BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS - MALEM KPN MALEM MEDICAL LTD. M05RB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention