BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 SELF -TEST

    MDR report key: 12587203 · Received October 6, 2021

    Report

    Report Number
    1221359-2021-03083
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 7, 2021
    Report Date
    December 2, 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

    THE CUSTOMER REPORTED STINGING IN THEIR EYES AFTER THE REAGENT WAS SQUIRTED IN THEIR EYES. TECHNICAL SERVICES ADVISED THE CUSTOMER TO FLUSH THEIR EYE WITH COPIOUS AMOUNTS OF WATER AND TO SEEK MEDICAL ATTENTION IF IRRITATION PERSISTS. TECHNICAL SERVICES COULD NOT PROVIDE THE SDS. ACCORDING TO THE PACKAGE INSERT IN195150C V3.0: 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. BASED ON THE ABOVE SUMMARY THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA - D1 AND G4 ADDTIONAL INFORMATION PROVIDED - G1 AND D3.

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE USER REPORTED WHEN ADDING DROPS FROM THE DROPPER BOTTLE, SOME OF THE LIQUID SQUIRTED TO THE USER'S WIFE'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484575 BINAXNOW COVID-19 SELF -TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 148988 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other