BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 5869610 · Received August 11, 2016

    Report

    Report Number
    1460851-2016-00004
    Event Type
    Injury
    Date Received
    August 11, 2016
    Report Date
    August 11, 2016
    Manufacturer
    BIGWALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED USING THE STEAM INHALER WITH FACE MASK ADAPTOR WITH AN ADDED VAPOR SOLUTION. ACCORDING TO THE USER, THE USER SUSTAINED BURNS TO HER FACE WHEN USING THE UNIT. THIS PRODUCT WAS RECALLED FROM STORES IN (B)(6) 2015. UNIT INSTRUCTIONS STATE THAT USERS SHOULD "NOT USE ADDITIVES" AND TO "USE WATER ONLY". THE PRODUCT SUPPLIER, (B)(4), SUBMITTED AN ADVERSE EVENT REPORT ON (B)(6) 2016 (REPORT # (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520432 WELL AT WALGREENS PERSONAL STEAM INHALER KFZ BIGWALL ENTERPRISES PJ1011

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other