BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAZ

    MDR report key: 2465657 · Received January 26, 2012

    Report

    Report Number
    MW5024317
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 26, 2012
    Manufacturer
    KAZ
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE INHALING (2 INCHES AWAY) THE STEAM FOR APPROX 15 MINUTES SHE NOTICED SHE BEGAN TO FEEL ILL AND THERE WAS AN OBNOXIOUS ODOR COMING FROM THE FUNNEL. SHE POWERED IT OFF AND UNPLUGGED AND BEGAN TO EXPERIENCE A HEADACHE. ON (B)(6) 2012 SHE FOLLOWED THE STEPS FROM THE PREVIOUS DAY AND NOTICED THAT THE FUMES WERE STILL THERE AND SHE HAD A RECURRING HEADACHE. SHE WASHED THE FUNNEL PER THE INSTRUCTIONS ON THE PACKAGING WITH WARM WATER. SHE HAS DISCONTINUED THE USE OF THE PRODUCT BECAUSE OF THE SYMPTOMS IT CAUSED HER TO EXPERIENCE. SHE DID NOT CONTACT THE FIRM AND INDICATED THAT SHE WOULDN'T. (B)(4). THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ ELECTRIC STEAM INHALER KFZ KAZ V1200

    Patients

    Seq Age Sex Outcome Treatment
    1