BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEDWETTING ALARM

    MDR report key: 8069400 · Received November 13, 2018

    Report

    Report Number
    MW5081205
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MALEM MEDICAL 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

    THERE IS SOMETHING NOT RIGHT WITH THE BED-WETTING ALARM THAT WE PURCHASED. IT IS A MALEM BRAND AND WAS PURCHASED AT THE RECOMMENDATION OF A PEDIATRICIAN. THE ALARM IS HEATING UP WHEN THE SENSOR IS CONNECTED. THE BACK CASING OF THE ALARM IS HOT AND NOT TOUCHABLE. IT WAS RECEIVED 4 NIGHTS AGO AND HAS NEVER FUNCTIONED CORRECTLY. WHEN THE SENSOR IS CONNECTED, EVEN WITH THE LATCH UP, THE ALARM IS VIBRATING AND GETTING HOT. I LET IT SIT FOR 30 MINS AND IT WAS EXTREMELY HOT AND I COULD NOT EVEN TOUCH IT. SURELY SOME MECHANICAL OR ELECTRICAL PROBLEM. HOW IS A CHILD EXPECTED TO WEAR SUCH A PRODUCT AND SLEEP AT NIGHT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902646 BEDWETTING ALARM ALARM, CONDITIONED RESPONSE KPN MALEM MEDICAL LTD. M04S

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention