BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED WETTING ALARM

    MDR report key: 6022193 · Received October 9, 2016

    Report

    Report Number
    MW5065338
    Event Type
    Injury
    Date Received
    October 9, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 9, 2016
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I HAD RECOMMENDED AN ENURESIS ALARM FOR MY PATIENT. THE MOTHER PURCHASED THE DEVICE FOR TREATMENT OF PRIMARY NOCTURNAL ENURESIS AT (B)(6). THE MOTHER FOLLOWED ALL INSTRUCTIONS FOR USE AND WHEN BATTERIES WERE INSERTED IN THE ALARM TO POWER ON, THE MOTHER ATTACHED IT TO THE SUBJECTS T-SHIRT AND LEFT FOR THE NIGHT. AT NIGHT, THE ALARM OVERHEATED AND EXPLODED CAUSING SEVERE BURNS TO THE CHILD. THE MOTHER CALLED ME UP IMMEDIATELY AND DISCONTINUED THE PRODUCT. THE CHILD HAS BURN MARKS ON HIS NECK AND SCARRING WHICH COULD HAVE BEEN MORE SERIOUS IF NOT ADDRESSED APPROPRIATELY. DIAGNOSIS OR REASON FOR USE: PRIMARY NOCTURNAL ENURESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664670 BED WETTING ALARM BED WETTING ALARM KPN MALEM MEDICAL M04

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening