MAUDE Adverse Event Report: PILOT COVID 19 AT HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 53K38P2T1

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

Patient Problems Conjunctivitis (1784); Unspecified Eye / Vision Problem (4471)

Event Date 04/19/2023

Event Type  Injury  

Event Description

My husband took one of the affected covid 19 tests on (b)(6) 2023 (lot# 53k38p2t1) and got conjunctivitis in his eye and his sickness worsened.He went to the dr on 4/28 and was given antibiotics.

• Brand Name: PILOT COVID 19 AT HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 16902716
• MDR Text Key: 314984040
• Report Number: MW5117409
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 53K38P2T1
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Hispanic