BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERCEPT ORAL

    MDR report key: 549930 · Received July 31, 2004

    Report

    Report Number
    MW1032881
    Event Type
    Other
    Date Received
    July 31, 2004
    Date of Event
    July 31, 2004
    Report Date
    July 31, 2004
    Manufacturer
    ORASURE
    Product Code
    MVO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    USE OF ORASURE ORAL INTERCEPT DRUG TEST RESULTED IN GLUTEN ALLERGIC RESPONSE. NO ALLERGY WARNING PROVIDED BY MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERCEPT ORAL DRUG SCREEN MVO ORASURE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other