BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS ISOLATION GOWN-YELLOW

    MDR report key: 2894706 · Received November 13, 2008

    Report

    Report Number
    2894706
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 4, 2008
    Product Code
    OEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SB, PT CARE TECH, DONNED A YELLOW BARRIER GOWN FOR FIRST TIME SINCE THIS FACILITIES CONVERSION TO THIS PRODUCT. WITHIN 15 TO 20 MINUTES HE NOTICED THAT HIS ARMS AND NECK WHERE THE SKIN WAS IN CONTACT WITH THE GOWN BEGAN TO FEEL VERY WARM AND ITCHY. HE STATES HE COULD SEE THRU THE GOWN THAT HIS SKIN WAS "BEET RED." HE THEN NOTICED THAT HIS EYES FELT SWOLLEN. HE REMOVED THE GOWN, NOTIFIED THE RN AND CAME TO CLINIC MGR'S OFFICE. HE HAD MARKED ERYTHEMA OF HIS FACE, NECK AND ARMS AND HIS EYELIDS WERE SWOLLEN AND NEARLY SHUT. HIS SKIN FELT COLD TO TOUCH, BUT WAS DRIPPING WET. HE DENIES SOB, BUT SAID HE FELT VERY ANXIOUS. 911 WAS CALLED; WHILE AWAITING THEIR ARRIVAL HE TOOK ORAL BENADRYL AND WASHED ALL SKIN AREA WHICH HAD CONTACTED GOWN. SYMPTOMS BEGAN TO SUBSIDE RAPIDLY AND WHEN SQUAD ARRIVED NO TREATMENT WAS GIVEN. HE REPORTED THE NEXT DAY THAT HE TOOK BENADRYL AGAIN THAT NIGHT AND SKIN WAS STILL SLIGHTLY REDDENED AND A LITTLE ITCHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMS ISOLATION GOWN-YELLOW NONE OEA 5743-00

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other