BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 5742298 · Received June 22, 2016

    Report

    Report Number
    1460851-2016-00001
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    February 6, 2016
    Report Date
    March 4, 2016
    Manufacturer
    BIGWALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE COMPLAINT SUPPLIED BELOW, CONSUMER ALLEGED THAT THE STEAM INHALER BLEW UP CAUSING THIRD DEGREE FACIAL BURNS. THIS COMPLAINT HAS BEEN PROVIDED TO THE SUPPLIER FOR INVESTIGATION. THE PRODUCT WAS RECALLED FROM (B)(6) STORES IN (B)(6). SUPPLIER FOR THIS PRODUCT TO (B)(6) IS BIGWALL ENTERPRISES. CONSUMER STATEMENT: MY MOM IS (B)(6) YEARS OLD AND SHE USED THIS STEAM INHALER AND IT BLEW UP IN HER FACE AND GAVE HER 3RD DEGREE BURNS. SHE HAS BURNS ON THE INSIDES OF HER EYES AND BLISTERS ON HER NOSE. I TOOK IT BACK TO THE STORE AND (B)(6) TOLD ME THAT THEY HAD ALREADY BEEN PULLED AND RECALLED AND SHE TOLD ME TO CALL YOU. MY MOM HAS BURNS ON HER NOSE AND UNDER HER EYES AND SCABS ARE FORMING. SHE ALSO HAS SOME VISION LOSS IN HER EYE, AND IT'S TOO EARLY TO TELL IF THIS IS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396412 WELL AT WALGREENS STEAM INHALER KFZ BIGWALL ENTERPRISES PJ1011

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other