BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEDWETTING ALARM

    MDR report key: 7063311 · Received November 28, 2017

    Report

    Report Number
    MW5073573
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 14, 2017
    Report Date
    November 22, 2017
    Manufacturer
    MALEM MEDICAL UK
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    BATTERIES IN OUR BEDWETTING ALARM LEAKED OUT AT NIGHT WHEN CHILD WAS SLEEPING. THE BEDWETTING ALARM WAS BRAND NEW AND JUST ARRIVED 1 DAY PRIOR TO USE. ALL WE DID WAS PUT BATTERIES IN THE ALARM UNIT AND PUT OUR DAUGHTER TO BED. IT TOOK ABOUT 30 MINUTES FOR THE ALARM TO GET HOT AND BATTERIES INSIDE TO EXPLODE AND LEAK. THE BATTERY LEAK WAS A DARK BLACK SLIMY SUBSTANCE WHICH BURNT MY CHILD'S NECK. WE HAVE USED THE BATTERIES THAT CAME WITH THE PRODUCT AND USED EXACTLY AS INSTRUCTED. THIS IS A PRODUCT DEFECT AND A DANGEROUS ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841948 BEDWETTING ALARM BEDWETTING ALARM KPN MALEM MEDICAL UK M04

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention