BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 7037479 · Received November 15, 2017

    Report

    Report Number
    MW5073382
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BIG WALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT THEIR (B)(6) CHILD WAS USING THE WARM STEAM PERSONAL INHALER AND THE INHALER MALFUNCTIONED WHEREIN THE STREAM SHOT UP INTO THE CHILD'S FACE AND CAUSED INJURIES THAT RESULTED IN A VISIT TO AN EMERGENCY ROOM FOR TREATMENT. THE PRODUCT WAS DISCONTINUED FOR SALE IN (B)(6) AS OF (B)(6). THE PRODUCT WAS RECALLED (B)(6) AND HAS NOT BEEN SOLD IN (B)(6) SINCE THAT DATE. REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814476 WELL AT WALGREENS WARM STEAM PERSONAL INHALER KFZ BIG WALL ENTERPRISES PJ011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other