BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 5743237 · Received June 22, 2016

    Report

    Report Number
    1460851-2016-00002
    Event Type
    Injury
    Date Received
    June 22, 2016
    Report Date
    June 22, 2016
    Manufacturer
    BIGWALL ENTERPRISES
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER ALLEGED THAT DAUGHTER ACCIDENTLY TOUCHED STEAM MASK ON THE STEAM INHALER CAUSING THE UNIT TO TIP OVER, SPILL WATER ONTO HER KNEE, AND BURN THE USER. INSTRUCTIONS FOR THE PRODUCT INDICATE THAT CHILDREN SHOULD BE CAREFULLY SUPERVISED WHEN USING THIS PRODUCT. THIS PRODUCT WAS RECALLED FROM (B)(6) STORES IN (B)(6) 2015 AND IS NO LONGER AVAILABLE TO CONSUMERS TO PURCHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397584 WELL AT WALGREENS STEAM INHALER KFZ BIGWALL ENTERPRISES PJ1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other