BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    MDR report key: 12174237 · Received July 15, 2021

    Report

    Report Number
    1221359-2021-01969
    Event Type
    Injury
    Date Received
    July 15, 2021
    Report Date
    December 2, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED B1, D1, H1.

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: TECHNICAL SERVICES ATTEMPTED TO COLLECT ADDITIONAL INFORMATION REGARDING ANY INTERVENTIONS TAKEN RELATED TO THE REAGENT SPRAY, NONE RECEIVED FROM 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. A TEST PERFORMANCE DEFICIENCY WAS NOT IDENTIFIED AND NO FURTHER ACTION IS REQUIRED THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 1

    THE CONSUMER WAS PROVIDED WITH THE REAGENT SAFETY DATA SHEET (SDS). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT SHE SPRAYED SOME REAGENT ON HER FACE WHILE TRYING TO OPEN IT. TECHNICAL SERVICES REQUESTED THAT THE CONSUMER THAT CUSTOMER HOLD TWO MINUTES TO BE TRANSFERRED TO RECEIVE HELP FOR HER CONCERN. THE CONSUMER DECLINED ANY FURTHER ASSISTANCE AND MENTIONED SHE KNEW HOW TO HANDLE THE TEST, SHE JUST WANTED TO REPORT THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073267 BINAXNOW COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153658

    Patients

    Seq Age Sex Outcome Treatment
    1 Female