BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICKS

    MDR report key: 2033309 · Received March 17, 2011

    Report

    Report Number
    1314800-2011-00012
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 15, 2011
    Manufacturer
    KAZ INC
    Product Code
    KFZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED BECOMING SICK FROM THE FUNGAL INFECTION HE CLAIMS WAS CAUSED BY THE HUMIDIFIER. HE STATED THERE WAS MOLD INSIDE THE UNIT WHICH CAUSED THE INFECTION. THE CONSUMER CLAIMED HE COULD NOT CLEAN THE UNIT WELL ENOUGH TO PREVENT THE MOLD, THE OWNERS MANUAL CONTAINS PROPER CLEANING INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICKS HUMIDIFIER KFZ KAZ INC V4450 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other