BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BED WETTING ALARM

    MDR report key: 6202820 · Received December 22, 2016

    Report

    Report Number
    MW5066897
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 21, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MALEM
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WE PURCHASED A BEDWETTING ALARM AND USED IT FOR THE FIRST TIME LAST NIGHT. THE PRODUCT IS SIMPLE. IT HAS A SENSOR AND A COMPACT ALARM UNIT WHICH CONNECTS TO THE SENSOR. THE SENSOR IS PLACED ON THE OUTSIDE OF THE UNDERWEAR AND THE ALARM UNIT IS CLIPPED ON THE TOP OF THE T-SHIRT. I SAW AN AD ON (B)(6) WHICH DIRECTED ME TO THE MANUFACTURER'S WEBSITE - (B)(6). I PURCHASED A MALEM BEDWETTING ALARM FOR MY (B)(6) SON AND WE TRIED IT FOR THE FIRST TIME LAST NIGHT. I SET IT UP AS PER INSTRUCTIONS AND PUT MY SON TO SLEEP. WITHIN 10 MINUTES, THE BACK OF THE ALARM GOT SO HOT THAT IT PARTIALLY MELTED AND BURNT A HOLE THROUGH MY SON'S PAJAMA TOP. HOW CAN A BED WETTING PRODUCT DO THIS? ISN'T THERE ANY QUALITY CONTROL FOR THIS PRODUCT? I HAD TO RUSH MY CHILD TO THE EMERGENCY ROOM AND REPORTED THE INCIDENT TODAY MORNING TO THE MANUFACTURER WHO TOLD ME THAT IT WAS A SAFE PRODUCT AND THAT THIS IS USER ERROR. I JUST PUT IN BATTERIES AND LITERALLY EXPLODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848718 MALEM BED WETTING ALARM BED WETTING ALARM KPN MALEM BLUE COLOR SINGLE TONE

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention OTC MEDS: CENTRUM KIDS.| RX MEDS: NA