BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 13388766 · Received January 28, 2022

    Report

    Report Number
    1314800-2022-00003
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    December 22, 2021
    Report Date
    January 26, 2022
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    KFZ
    UDI-DI
    00049022459779
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT SHE RECEIVED THIRD DEGREE BURNS ON HER ARM FROM THE HOT STEAM THAT WAS BEING PRODUCED BY THE VAPORIZER DURING USE. SHE STATED THAT HER INJURIES OCCURRED WHEN SHE QUICKLY REACHED OVER THE STEAM OUTPUT DURING USE. MEDICAL INTERVENTION WAS SOUGHT FOR HER INJURIES SIX DAYS AFTER THE INCIDENT OCCURRED. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS WHICH STATE "DO NOT TOUCH THE STEAM VAPOR. STEAM CAN CAUSE BURNS.", AS WELL AS A WARNING ON THE DEVICE ITSELF WHICH STATES, "WARNING KEEP OUT OF REACH OF CHILDREN HOT STEAM CAN CAUSE SERIOUS BURN INJURY." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762912 WALGREENS VAPORIZER KFZ KAZ USA, INC., A HELEN OF TROY COMPANY 2100-WGN UNKNOWN 00049022459779

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R