BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORASURE ORAL SPECIMEN COLLECTION DEVICE

    MDR report key: 757798 · Received August 24, 2006

    Report

    Report Number
    2528909-2006-00002
    Event Type
    Other
    Date Received
    August 24, 2006
    Date of Event
    August 3, 2006
    Report Date
    August 23, 2006
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    LIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC LOT USED DURING THE COLLECTION WAS NOT IDENTIFIED. NO ABNORMALITIES HAVE BEEN IDENTIFIED IN RELEASED PRODUCTION LOTS. MSDS SHEET ATTACHED.

    Description of Event or Problem · 1

    A RESIDENT PROVIDED AN ORAL FLUID SAMPLE USING THE ORASURE COLLECTION DEVICE COLLECTED BY COMPANY ON OR ABOUT AUGUST 2, 2006. THE FOLLOWING DAY THE CLIENT REPORTED AN ALL OVER RASH AFTER COLLECTION WAS PERFORMED. THE RASH APPEARED ON HIS ARM, FACE AND TRUNK, THE SKIN WAS INFLAMMED AND ITCHY. THE ORASURE CUSTOMER SUPPORT STAFF ADVISED TO SEEK MEDICAL ATTENTION AND OFFERED THE INGREDIENTS OF THE COLLECTION DEVICE AND THE MSDS SHEET. REPORTER WAS CONTACTED BY ORASURE TECHNOLOGIES, INC. ON AUGUST 7, 2006. THE SOCIAL WORKER REPORTED THAT THE CLIENT REFUSED MEDICAL ATTENTION, BUT TOOK A COUPLE OF BENADRYL AND BY THAT EVENING THE RASH WAS MUCH IMPROVED AND THE FOLLOWING DAY THE RASH WAS GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORASURE ORAL SPECIMEN COLLECTION DEVICE ORAL FLUID COLLECTOR LIO ORASURE TECHNOLOGIES, INC. 503-0050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other