BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 15620906 · Received October 18, 2022

    Report

    Report Number
    2531491-2022-00012
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    October 5, 2022
    Report Date
    December 21, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION HAS BEEN UPDATED FROM THE INITIAL REPORT UPON COMPLETION OF THE INTERNAL INVESTIGATION. THE FOLLOWING FIELDS ARE UPDATED: B4, "DATE OF THIS REPORT" - DATE OF FOLLOW-UP REPORT. G6, "TYPE OF REPORT" - FOLLOW-UP #1. H2, "IF FOLLOW-UP, WHAT TYPE?" - UPDATED TO "ADDITIONAL INFORMATION." H6 "ADVERSE EVENT PROBLEM" - EVENT PROBLEM AND EVALUATION CODES SUCH AS "INVESTIGATION FINDINGS" AND "INVESTIGATION CONCLUSIONS" ARE ADDED PER INVESTIGATION. H10 "ADDITIONAL NARRATIVE/DATA" - ADDED MANUFACTURER'S NARRATIVE.

    Description of Event or Problem · 0

    END USER REPORTED BURNING IRRITATION IN HER NOSTRIL AFTER PERFORMING SWAB EXTRACTION. THE USER VERIFIED THERE WAS NO EXTRACTION BUFFER ON THE SWAB BEFORE SWABBING HER NOSTRIL, AND THE SWAB WAS SEALED IN ITS PACKAGING PRIOR TO SWABBING. NO MEDICAL ASSISTANCE WAS RECEIVED BY THE USER.

    Description of Event or Problem · 0

    END USER REPORTED BURNING IRRITATION IN HER NOSTRIL AFTER PERFORMING SWAB EXTRACTION. THE USER VERIFIED THERE WAS NO EXTRACTION BUFFER ON THE SWAB BEFORE SWABBING HER NOSTRIL, AND THE SWAB WAS SEALED IN ITS PACKAGING PRIOR TO SWABBING. NO MEDICAL ASSISTANCE WAS RECEIVED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391470 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other