BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCEPT ORAL SPECIMEN COLLECTION DEVICE

    MDR report key: 4172557 · Received October 10, 2014

    Report

    Report Number
    3004142665-2014-00006
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    JKA
    PMA / PMN Number
    K011057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A WOMAN SWABBED WITH THE INTERCEPT ORAL COLLECTION DEVICE ON (B)(6) 2014. SHE REPORTED THAT SHE HAS HAD A BAD TASTE IN HER MOUTH AND FEELS SOMETIMES NAUSEA EVER SINCE SHE SWABBED WITH THE INTERCEPT DEVICE. SHE STATED THAT SHE FEELS MUCH BETTER AS OF (B)(6) 2014 THAN SHE FELT A FEW MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642899 INTERCEPT ORAL SPECIMEN COLLECTION DEVICE NONE JKA ORASURE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other