BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCEPT ORAL SPECIMEN COLLECTION DEVICE

    MDR report key: 3779152 · Received April 17, 2014

    Report

    Report Number
    3004142665-2014-00003
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    JKA
    PMA / PMN Number
    K011057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AT 3:00PM ON (B)(6) 2014, THE CLIENT SELF-ADMINISTERED ON INTERCEPT ORAL FLUID DRUG TEST. SHE REPORTED SOME TINGLING INITIALLY THEN MORE OF A STINGING AND BURNING SENSATION. AT 5.5 HOURS LATER, AT 8:30PM THE CLIENT REPORTED NOTICING SWELLING OF THE CHEEK AREA AND SAW BLISTERS IN HER MOUTH. AT THIS TIME, SHE WAS EVALUATED BY A FACILITY NURSE ON DUTY. ON (B)(6) 2014 AT APPROXIMATELY 4:10PM, SHE WAS SEEN AT TRI-AREA COMMUNITY HEALTH CENTER WHERE SHE RECEIVED A DIAGNOSIS OF MOUTH REACTIVE ULCERS AND WAS PRESCRIBED MAGIC MOUTHWASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236546 INTERCEPT ORAL SPECIMEN COLLECTION DEVICE NONE JKA ORASURE TECHNOLOGIES INC. 6637254

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other