BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 20161654 · Received September 6, 2024

    Report

    Report Number
    2531491-2024-00118
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM OUR CONTRACT MANUFACTURER, AND WE WILL PROVIDE FOLLOW UP MDR UPON INVESTIGATION COMPLETION SUCH AS REVIEW OF BATCH RECORDS OR TESTING OF RETENTION SAMPLES. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.

    Additional Manufacturer Narrative · 0

    CASE OUTCOME: BATCH RECORDS FOR COV3100001 WERE REVIEWED AND NO ABNORMAL ISSUE WAS FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS WAS COMPLIED WITH THE DMR. RETENTION SAMPLES OF THIS BATCH WERE TESTED, AND NO RELATED ISSUE WAS FOUND. THE SWAB SUPPLIER WAS CONTACTED TO CONDUCT A FURTHER INVESTIGATION. REFER TO THE DETAILS BELOW: 1) FROM THE MANUFACTURING PROCESS OF THE SWAB, THE FOAM WAS BONDED ON THE PP ROD BY HEAT PRESS, THEN THE SWABS WERE PACKAGED IN THE PLASTIC-PAPER BAG IN THE CLEAN ROOM, AND SENT TO THE EO STERILIZATION. AFTER STERILIZATION, THE SWABS WERE TESTED, INCLUDING THE STERILE TEST, EO RESIDUAL TEST ETC. AFTER PASSING ALL THE TESTS, THE PRODUCT WAS RELEASED FOR SHIPPING. 2) THE MATERIALS AND THE PRODUCTION PROCESS WERE REVIEWED, THERE WAS NO CHANGE ON THE MATERIALS OR THE PROCESS, THE SWAB IS MADE UP OF PP ROD AND PU FOAM HEAD, THEY ARE COMBINED BY THE HEAT PRESS. IN THE WHOLE PROCESS, THERE'S NO CHEMICAL SUBSTANCES USED. 3) REVIEW OF THE MATERIALS IN THE WHOLE MANUFACTURING PROCESS, THERE'S NO CHEMICAL SUBSTANCES WAS USED, AND ALSO NO CHANCE TO CONTACT WITH ANY OF CHEMICAL SUBSTANCES. 4) BIOCOMPATIBILITY TESTS HAVE BEEN DONE FOR THE SWAB, WHICH CAN PROVE THE COMPLIANCE OF THE BIOCOMPATIBILITY OF THE FLOCKED SWABS, AND NOT TOXIC TO HUMANS. BASED ON THE INVESTIGATION, IT COULD BE CONCLUDED THAT THE PRODUCTION PROCESS OF THIS BATCH WAS NORMAL, THERE'S NO CHANGE IN THE MATERIALS OR THE PROCESS, AND NO CHEMICAL SUBSTANCES WERE USED IN THE WHOLE PROCESS, AND NO IRRITATING SUBSTANCES WERE FOUND. THEREFORE, IT IS CONSIDERED AS AN ISOLATED ISSUE AND MAY BE RELATED TO A PARTICULAR PATIENT'S SUSCEPTIBILITY. THE ROOT CAUSE IS STILL NOT DECIDED, WE WILL TRACE SIMILAR ISSUES. 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" AND "DEVICE EVALUATION" 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

    SWAB ISSUE. THE USER STATED THAT THE NASAL SWAB CAUSED HER TO HAVE A VERY BAD REACTION. THE USER STATED THAT THEIR NOSTRILS FELT NUMB AFTER PERFORMING THE SWABBING PROCEDURE. THE USER REPORTED DRY HEAVING AND THAT THEIR EARS AND LIPS STARTED TO EXPERIENCE A BURNING SENSATION. THE USER REPORTED THAT THE PALMS OF THEIR HANDS AND FEET AND PRIVATES EXPERIENCED AN ITCHING SENSATION. THE USER REPORTED EXPERIENCING A HORRIBLE TASTE IN THEIR MOUTH THAT TASTED LIKE CHEMICALS. THE USER REPORTED TAKING TWO BENADRYL AND FELT VERY SICK THE REST OF THE DAY. THE USER REPORTED THAT WITHIN THE HOUR THEY STARTED TO HAVE SHOOTING PAINS IN THEIR BONES. THE USER STATED THAT THEY ARE VERY SENSITIVE TO CHEMICALS. THE USER CONFIRMED THAT THEY DID NOT SEEK ANY ADDITIONAL MEDICAL TREATMENT. THE USER CONFIRMED THAT THE INSIDE OF THEIR NOSE IS STILL A LITTLE BIT NUMB BUT THE FEELING IS GOING AWAY OVER TIME. THE USER CONFIRMED THAT THEY INSERTED THE SWAB THE RECOMMENDED AMOUNT OUTLINED IN THE PI.

    Description of Event or Problem · 0

    SWAB ISSUE. THE USER STATED THAT THE NASAL SWAB CAUSED HER TO HAVE A VERY BAD REACTION. THE USER STATED THAT THEIR NOSTRILS FELT NUMB AFTER PERFORMING THE SWABBING PROCEDURE. THE USER REPORTED DRY HEAVING AND THAT THEIR EARS AND LIPS STARTED TO EXPERIENCE A BURNING SENSATION. THE USER REPORTED THAT THE PALMS OF THEIR HANDS AND FEET AND PRIVATES EXPERIENCED AN ITCHING SENSATION. THE USER REPORTED EXPERIENCING A HORRIBLE TASTE IN THEIR MOUTH THAT TASTED LIKE CHEMICALS. THE USER REPORTED TAKING TWO BENADRYL AND FELT VERY SICK THE REST OF THE DAY. THE USER REPORTED THAT WITHIN THE HOUR THEY STARTED TO HAVE SHOOTING PAINS IN THEIR BONES. THE USER STATED THAT THEY ARE VERY SENSITIVE TO CHEMICALS. THE USER CONFIRMED THAT THEY DID NOT SEEK ANY ADDITIONAL MEDICAL TREATMENT. THE USER CONFIRMED THAT THE INSIDE OF THEIR NOSE IS STILL A LITTLE BIT NUMB BUT THE FEELING IS GOING AWAY OVER TIME. THE USER CONFIRMED THAT THEY INSERTED THE SWAB THE RECOMMENDED AMOUNT OUTLINED IN THE PI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360505 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. COV3100001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown