BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6315711 · Received February 9, 2017

    Report

    Report Number
    1460851-2017-00003
    Event Type
    Injury
    Date Received
    February 9, 2017
    Report Date
    February 9, 2017
    Manufacturer
    BIG WALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT HER HUSBAND WAS USING THE PRODUCT WHEN THE UNIT SPUTTERED AND CAUSED HOT WATER TO BURN THE 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) SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100644 WELL AT WALGREENS WARM STEAM PERSONAL INHALER KFZ BIG WALL ENTERPRISES PJ011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other