BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 15006568 · Received July 13, 2022

    Report

    Report Number
    1221359-2022-03583
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    July 1, 2022
    Report Date
    July 13, 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

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICE WAS UNABLE TO SEND THE CUSTOMER THE RELEVANT SDS SHEET. TECHNICAL SERVICE MADE THREE ATTEMPTS AT CONTACTING THE CUSTOMER FOR ADDITIONAL INFORMATION BUT WAS UNSUCCESSFUL. 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. BASED ON THE ABOVE SUMMARY THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SWABBING HER NOSTRILS WITH THE BINAXNOW EXTRACTION REAGENT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063245 BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 188771 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other