MAUDE Adverse Event Report: COVID 19 TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Visual Impairment (2138)

Event Date 02/07/2023

Event Type  Injury  

Event Description

Patient called to report an incident with a covid test kit that was administered by a caretaker whom came to her home to give her the test.The first test was administered on (b)(6) 2023 with a positive result and no adverse event.The second test was administered approximately a week later.Patient stated she inserted the swab into her left nostril and swirled seven times as instructed.The next day after the second test (sunday), she lost vision in her left eye where she has no front vision and very little peripheral vision.Patient states that she may have put the cotton swab too deep into her left nostril.Patient visited her ophthalmologist who checked her eyes and found a dense cataract but no other damage and could not find a cause for the visual loss of her left eye.

• Brand Name: COVID 19 TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 16418648
• MDR Text Key: 310084123
• Report Number: MW5115102
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Female