BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS PERSONAL WARM STEAM INHALER

    MDR report key: 4795537 · Received May 22, 2015

    Report

    Report Number
    1460851-2015-00005
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    May 22, 2015
    Manufacturer
    POVOS
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS PROVIDED TO (B)(6) ON (B)(6) 2015 ALLEGING THAT HOT WATER SPILLED OUT OF A STEAM INHALER AND BURNED HER SON. THE COMPLAINT WAS PROVIDED, IN (B)(6) 2015, TO THE SUPPLIER BIG WALL ENTERPRISES, WHO ATTEMPTED TO FOLLOW-UP WITH THE COMPLAINANT. ACCORDING TO (B)(6) , THE COMPANY HAS TRIED TO CONTACT THE CONSUMER NUMEROUS TIMES THROUGH THE CONTACT INFORMATION PROVIDED BY THE CONSUMER TO VERIFY THE ALLEGATIONS IN THE COMPLAINT. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS COMPLAINT. DESPITE NOT BEING ABLE TO VERIFY THE ALLEGATIONS IN THIS COMPLAINT, (B)(6) HAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED TO FDA DUE TO PRESENCE OF OTHER ADVERSE EVENT COMPLAINTS THAT IT HAS RECENTLY BEEN MADE AWARE OF. THE PRODUCT NAMED IN THIS COMPLAINT IS THE (B)(6) PERSONAL STEAM INHALER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337344 WALGREENS PERSONAL WARM STEAM INHALER STEAM INHALER CAF POVOS PJ1011 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK