MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST

Model Number 20402

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/25/2022

Event Type  malfunction  

Event Description

Qv sars otc: consumer reported nose bleeding after swabbing the nostrils.Tss documenting.

Manufacturer Narrative

Investigation conclusion: a review of complaint history did not identify any adverse trends.Investigation summary: in response to your complaint, we reviewed the complaint history log for this lot and no significant trend was identified.The information you provided has been documented and will continue to be monitored for future trends.Root cause: unable to determine.Source: phone: (b)(6).

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: QUICKVUE AT-HOME OTC COVID-19 TEST
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 16061875
• MDR Text Key: 306299976
• Report Number: 0002024674-2022-10678
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2022

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
• Device Model Number: 20402
• Device Catalogue Number: 20402
• Device Lot Number: NONE
• Initial Date Manufacturer Received: 12/25/2022
• Initial Date FDA Received: 12/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1