BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6294295 · Received February 1, 2017

    Report

    Report Number
    1460851-2017-00002
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    December 18, 2016
    Report Date
    February 1, 2017
    Manufacturer
    BIG WALL 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

    MANUFACTURER NOTIFIED WALGREEN CO. THAT CONSUMER WAS HEATING THE WATER AND WAS GETTING READY TO USE THE PRODUCT WHEN THE FACE MASK POPPED OFF THE UNIT, CAUSING HOT WATER TO POUR ONTO THE USERS CHEST AND NECK. THE MANUFACTURER (BIGWALL ENTERPRISES) FILED AN ADVERSE EVENT REPORT UNDER THE NUMBER (B)(4). THIS PRODUCT WAS RECALLED IN NOVEMBER 2015 AND HAS NOT BEEN SOLD IN WALGREENS STORE SINCE THAT RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76601 WELL AT WALGREENS WARM STEAM PERSONAL INHALER KFZ BIG WALL ENTERPRISES PJ011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other