BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 SELF-TEST

    MDR report key: 15030067 · Received July 15, 2022

    Report

    Report Number
    1221359-2022-02450
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 27, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICES PROVIDED THE REAGENT SAFETY DATA SHEET TO THE CUSTOMER. ACCORDING TO THE PACKAGE INSERT IN195150C V. 3.0: PRECAUTIONS: 20. THE REAGENT SOLUTION CONTAINS A HARMFUL CHEMICAL (SEE TABLE BELOW). IF THE SOLUTION CONTACTS THE SKIN OR EYE, FLUSH WITH COPIOUS AMOUNTS OF WATER. IF IRRITATION PERSISTS, SEEK MEDICAL ADVICE: HTTPS://WWW.POISON.ORG/ CONTACT-US OR 1-800-222-1222.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED ON LIQUID REAGENT INSERTED WITH SWAB INTO NOSTRIL WITH BINAXNOW COVID 19 ANTIGEN SELF-TEST ON (B)(6) 2022.THE CUSTOMER STATED THAT SHE INSERTED THE SWAB WITH THE LIQUID REAGENT INTO HER BOTH NOSTRILS. THE CONSUMER DID NOT TAKE ANY REMEDIAL ACTION, DUE TO THE FACT THAT IT WAS NOT REQUIRED, JUST A WEIRD TASTE IN MOUTH AFTERWARDS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046684 BINAXNOW COVID-19 SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 190140 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other