MAUDE Adverse Event Report: CORONAVIRUS TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problems Burn(s) (1757); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/21/2021

Event Type  Injury  

Event Description

Took the coronavirus test at (b)(6) and had severe lip burns and dryness causing them to split open.Way beyond chapped lips.

• Brand Name: CORONAVIRUS TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 11236141
• MDR Text Key: 229103579
• Report Number: MW5099007
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 01/23/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 99