BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6341503 · Received February 17, 2017

    Report

    Report Number
    1460851-2017-00004
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 17, 2017
    Manufacturer
    BIG WALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT SHE HAS USED THE PRODUCT FOR 10 TO 11 MONTHS WITHOUT ISSUE, BUT ON (B)(6) 2017, SHE NOTICED THAT THE WATER WAS BUBBLING IN THE DEVICE. SHORTLY THEREAFTER WATER SHOT UP FROM THE DEVICE AND BURNED HER FOREHEAD. CONSUMER SOUGHT MEDICAL ATTENTION AND REPORTS THAT THE BURNS WERE EITHER FIRST OR SECOND DEGREE. THIS PRODUCT WAS RECALLED IN NOVEMBER 2015 AND HAS NOT BEEN SOLD AT (B)(6) SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121812 WELL AT WALGREENS WARM STEAM PERSONAL INHALER KFZ BIG WALL ENTERPRISES PJ011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other