BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6081148 · Received November 7, 2016

    Report

    Report Number
    1460851-2016-00006
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    BIGWALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CONSUMER INDICATED THAT THEY WERE USING THE PRODUCT WITH THEIR DAUGHTER AND CLAIMED THAT WATER POPPED OUT OF THE STEAM INHALER AND BURNED THEIR DAUGHTER ON THE LIP AND CHEEK. CONSUMER INDICATED THAT THEY TOOK THEIR DAUGHTER TO URGENT CARE WHERE SHE RECEIVED A TETANUS SHOT AND ANTIBIOTICS. THE CONSUMER INDICATED THAT THEY USED (B)(6) LOTION WITH THE STEAM INHALER. USER INSTRUCTIONS STATE THAT USERS SHOULD "NOT USE ADDITIVES" AND TO "USE WATER ONLY." THIS PRODUCT HAD BEEN PREVIOUSLY 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
    733446 WELL AT WALGREENS PERSONAL STEAM INHALER KFZ BIGWALL ENTERPRISES PJ1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other