BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONAL COUGH & COLD STEAM INHALER

    MDR report key: 3193418 · Received June 24, 2013

    Report

    Report Number
    MW5030660
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    WALGREENS EAST WEST DISTRIBUTORY COMPANY
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT'S MOM STATES SHE FILLED PERSONAL STEAM INHALER WITH 2/3 CUP OF WATER, SECURED THE ATTACHMENT FOR THE FACIAL INHALER AND TURNED THE DEVICE ON. THE PT DECIDED SHE DID NOT WANT TO USE THE STEAM INHALER, SO HER MOTHER TURNED THE DEVICE OFF. AFTER A MINUTE LATER, SHE PICKED UP DEVICE AFTER MAKING SURE IT WAS SECURE. THE FACIAL ATTACHMENT/LID DETACHED FROM THE DEVICE CAUSING SCOLDING HOT WATER TO POUR ON PT'S LEFT ARM AND LEFT LEG. PT'S MOM TOOK HER DAUGHTER TO THE PEDIATRICIAN WHICH DIAGNOSIS HER DAUGHTER WITH A 1ST DEGREE BURN APPROX 8-10 INCHES LONG ON HER LEFT ARM AND A 2ND DEGREE BURN APPROX 8 INCHES ON HER LEFT LEG. THE PEDIATRICIAN PRESCRIBED OINTMENT, AND BANDAGE FOR PT. PT ALSO WENT TO A DERMATOLOGIST WHICH PRESCRIBED A BURN FILM BANDAGE, AND ANTIBIOTICS TO PREVENT INFECTION. THE PT'S MOTHER DESCRIBES THE BURN ON HER DAUGHTER'S LEG AS "BLISTERING, SKIN FALLING OFF, PURPLE IN COLOR, SKINLESS AND OOZING." PT MOM SAID SHE HAS USED HIS PRODUCT SEVERAL TIMES WITHIN THE PAST YEAR AND HAS NEVER HAD THIS ISSUE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285699 PERSONAL COUGH & COLD STEAM INHALER NONE CAF WALGREENS EAST WEST DISTRIBUTORY COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other