BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6418705 · Received March 20, 2017

    Report

    Report Number
    1460851-2017-00007
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 20, 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 REPORTED THAT WHILE USING THE PRODUCT, IT SPUTTERED HOT WATER ON USER'S FACE. THE USER HAS NOT REPORTED WHETHER THEY SOUGHT MEDICAL ATTENTION. THIS PRODUCT WAS RECALLED IN NOVEMBER 2015 AND HAS NOT BEEN SOLD AT (B)(6) STORES SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201293 WELL AT WALGREENS WARM STEAM INHALER KFZ BIG WALL ENTERPRISES PJ011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other