BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS PERSONAL WARM STEAM INHALER

    MDR report key: 4943424 · Received July 23, 2015

    Report

    Report Number
    1460851-2015-00007
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    May 6, 2015
    Report Date
    July 23, 2015
    Manufacturer
    BIGWALL ENTERPRISES
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT WHEN USING A STEAM INHALER PRODUCT WATER/STEAM CAME OUT OF THE MACHINE AND CAUSED BURNS TO THE USER'S FACE. CONSUMER INDICATED THAT THEY WERE TREATED BY URGENT CASE AND A DERMATOLOGIST FOR ALLEGED SECOND DEGREE BURNS. THE CONSUMER'S COMPLAINT IS PROVIDED WITH THIS REPORT AS ATTACHMENT A. THIS COMPLAINT HAS BEEN PROVIDED TO THE MANUFACTURER WHO WAS ABLE TO RECOVER THE PRODUCT FROM THE CONSUMER AND HAS INFORMED WALGREENS THAT THEY ARE INVESTIGATING THE INCIDENT. THE INCIDENT WAS ORIGINALLY REPORTED TO WALGREENS WITH THE WRONG PRODUCT NUMBER. ON 07/14/2015, WALGREENS LEARNED THAT THE PRODUCT INVOLVED WAS THE WALGREENS PERSONAL STEAM INHALER (WALGREENS WIC (B)(4)). AT (B)(6) PREGNANT I WAS HAVING CHALLENGES WITH NASAL CONGESTION AND BREATHING SO MY HUSBAND WENT TO (B)(6) AND THE ASSOCIATE RECOMMENDED ONE OF THE BEST DECONGESTANT OPTIONS WOULD BE THE WALGREENS PERSONAL STEAM INHALER. I USED THE PRODUCT FOR A FEW DAYS AND IT DID SEEM TO WORK WELL BUT ON THE MORNING OF (B)(6) AROUND 1:30AM WHILE USING THE PRODUCT ACCORDING TO THE DIRECTIONS OF THE STEAM/WATER EXPLODED CAUSING THE FACE MASK TO POP OFF THE BOTTOM STEAMER AND BURN MY FACE. WHEN I WENT TO URGENT CARE THEY TREATED ME FOR SECOND DEGREE BURNS BECAUSE OF BLISTERING AND THE DEPTH OF THE BURN TO MY FACE. DUE TO THE BURN BEING ON MY FACE AND NOT WANTING TO CAUSE PERMANENT SCARRING I WENT TO THE DERMATOLOGIST WHO ALSO SAID THE BURN WAS A SECOND DEGREE AND GAVE ME OINTMENTS TO KEEP IT MOISTURIZED. YOU CAN IMAGINE BEING (B)(6) PREGNANT AND THEN GETTING SECOND DEGREE BURNS TO MY FACE DID NOT CREATE A STRONG EMOTIONAL STATE. I HAD TO MISS MY NEPHEWS FIRST HOLY COMMUNION, MY TWO NIECES FIRST HOLY COMMUNION AND CONFIRMATIONS, ONE OF WHOM I WAS A SPONSOR FOR AS WELL AS MY NIECES 8TH GRADE PROMOTION ALONG WITH TWO WEEKS OF WORK BECAUSE I DID NOT WANT TO LEAVE THE HOUSE WITH THE DAMAGE THE BURN CAUSED TO MY FACE. MY FACE HAS BEEN HEALING BUT DO HAVE TWO REMAINING MARKS THAT ARE APPEARING DARKER THAN THE REST OF THE AREA WHERE THE BLISTERS WERE LOCATED THAT COULD LEAVE PERMANENT SCARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478240 WALGREENS PERSONAL WARM STEAM INHALER STEAM INHALER CAF BIGWALL ENTERPRISES PJ1011 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other