BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VERILY COVID-19 NASAL SWAB KIT

    MDR report key: 15255780 · Received August 18, 2022

    Report

    Report Number
    3013170399-2022-00002
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 18, 2022
    Manufacturer
    VERILY LIFE SCIENCES
    Product Code
    QLW
    PMA / PMN Number
    EUA 202054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS TO AMEND MDR NO. 3013170399-2022-00002 REGARDING USE OF THE FIELDS "SUMMARY REPORT BOX" "NUMBER OF EVENTS" WHICH IS NOT PERMITTED FOR COVID-19 TEST HOME COLLECTION KIT DEVICE (PRODUCT CODE (B)(6) ).

    Description of Event or Problem · 0

    ON (B)(6) 2022, VERILY RECEIVED REPORTS FROM AN UNSUPERVISED TESTING SITE INDICATING THAT THE NASAL SWABS FROM THE VERILY COVID-19 NASAL SWAB KIT BROKE DURING USE IN FIVE PARTICIPANTS. REPORTED ON (B)(6) 2022: ON (B)(6) 2022, THE FIRST INCIDENT WAS REPORTED TO VERILY BY A PARTICIPANT WHO PERFORMED A SELF TEST, INSERTED THE SWAB IN THE RIGHT NOSTRIL AND BEGAN TO SWAB BUT THE STEM SNAPPED WITHIN A FEW SECONDS. THE PARTICIPANT WAS STARTLED AND SNATCHED WHERE THEY THOUGHT THE REMAINING STEM SHOULD BE BUT WAS NOT USING A MIRROR AND MISSED, BUMPING THE SWAB END INTO SINUS. AFTER A FEW MINUTES, PARTICIPANT TRIED BLOWING WITHOUT SUCCESS AND WENT TO THE CAMPUS HEALTH SERVICE CENTER. A DOCTOR IN THE CAMPUS HEALTH SERVICE CENTER SUCCESSFULLY EXTRACTED THE BROKEN SWAB. NO OTHER SYMPTOMS OR COMPLICATIONS WERE REPORTED DUE TO THE EVENT. REPORTED ON JULY 18, 2022: ON JULY 15, 2022, A SECOND INCIDENT WAS REPORTED FROM THE SAME TESTING SITE WITH A PARTICIPANT INDICATING THAT THE NASAL SWAB BROKE OFF WHILE PERFORMING THE TEST. THE PARTICIPANT BEGAN WITH SWABBING HER LEFT NOSTRIL AND AROUND THE 5TH TURN, THE SWAB BROKE IN HALF AND BECAME LODGED INSIDE HER NASAL PASSAGE, LEAVING THE COTTON TIP STUCK IN HER NOSTRIL. THE PARTICIPANT WAS ABLE TO PULL THE SWAB OUT AND SAID THERE WAS NO PAIN OR DISCOMFORT. A THIRD INCIDENT WAS ALSO REPORTED BY THE SITE COORDINATOR ON THE SAME DAY BUT VERILY WAS UNABLE TO GATHER MORE INFORMATION DUE TO NO RESPONSE FROM THE PARTICIPANT. ON (B)(6) 2022, A FOURTH INCIDENT WAS REPORTED THAT THE NASAL SWAB BROKE OFF WHILE THE PARTICIPANT WAS PERFORMING THE TEST. THE SITE COORDINATOR STATED THAT THE PARTICIPANT WAS ABLE TO COMPLETE THE TEST AND SAFELY REMOVE THE SWAB WITH NO MEDICAL ASSISTANCE. ON (B)(6) 2022, A FIFTH INCIDENT WAS REPORTED BY THE SAME TESTING SITE. THE SITE COORDINATOR INDICATED THAT WHILE THE PARTICIPANT WAS PERFORMING THE TEST, A 14 MM PIECE SNAPPED OFF THE END OF THE SWAB AS THE PARTICIPANT HAD FINISHED SWABBING. THERE WAS NO OTHER REPORT OF MEDICAL INTERVENTION AND PARTICIPANT WAS ABLE TO COMPLETE THE TEST WITH NO COMPLICATIONS.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL IS TO AMEND MDR NO. 3013170399-2022-00002 REGARDING USE OF THE FIELDS "SUMMARY REPORT BOX" "NUMBER OF EVENTS" WHICH IS NOT PERMITTED FOR COVID-19 TEST HOME COLLECTION KIT DEVICE (PRODUCT CODE (B)(6) ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847708 VERILY COVID-19 NASAL SWAB KIT COVID-19 TEST KIT QLW VERILY LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention