BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW COVID-19 AG CARD

    MDR report key: 13804281 · Received March 18, 2022

    Report

    Report Number
    1221359-2022-01377
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TECHNICAL SERVICE PROVIDED SAFETY DATA SHEET TO THE CUSTOMER AND NO FURTHER ACTION IS REQUIRED. ACCORDING TO THE PACKAGE INSERT IN 195000 V 3.0 PRECAUTIONS 21. THE EXTRACTION REAGENT PACKAGED IN THIS KIT CONTAINS SALINE, DETERGENTS AND PRESERVATIVES THAT WILL INACTIVATE CELLS AND VIRUS PARTICLES. SAMPLES ELUTED IN THIS SOLUTION ARE NOT SUITABLE FOR CULTURE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED EXTRACTION REAGENT ON LIP WITH THE BINAXNOW COVID-19 AG CARD FOR PERFORMED ON (B)(6) 2022. PER CONSUMER, ADULT MALE SUFFERED A SKIN EXPOSURE TO HIS LIPS RESULTING IN NO SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29433 BINAXNOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other