MAUDE Adverse Event Report: VERILY LIFE SCIENCES VERILY COVID-19 NASAL SWAB KIT; COVID-19 TEST KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

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.

Event Description

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) ).

Manufacturer Narrative

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) ).

• Brand Name: VERILY COVID-19 NASAL SWAB KIT
• Type of Device: COVID-19 TEST KIT
• Manufacturer (Section D): VERILY LIFE SCIENCES; 249 e.grand avenue; south san francisco 94080
• Manufacturer (Section G): VERILY LIFE SCIENCES; 249 e.grand avenue; south san francisco 94080
• Manufacturer Contact: dinamarie stefani ; 269 e grand avenue; south san francisco, CA 94080 ; 6502530000
• MDR Report Key: 15255780
• MDR Text Key: 305511475
• Report Number: 3013170399-2022-00002
• Device Sequence Number: 1
• Product Code: QLW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA 202054
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention