BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICKS

    MDR report key: 2497878 · Received March 16, 2012

    Report

    Report Number
    1314800-2012-00014
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 15, 2012
    Manufacturer
    KAZ INC
    Product Code
    BTT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HER SON WAS INJURED BY THE WATER TANK OF THE HUMIDIFIER WHEN THE HANDLE BROKE OFF. THE TANK FELL ON HIS HEAD CAUSING A CUT THAT REQUIRED STITCHES. THE INSTRUCTIONS FOR USE RECOMMEND ALWAYS CARRYING THE WATER TANK USING BOTH THE TOP AND BOTTOM HANDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICKS HUMIDIFIER BTT KAZ INC V745A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other