MAUDE Adverse Event Report: CORONA VIRUS NASAL TEST; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

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

Patient Problem Pain (1994)

Event Date 06/27/2020

Event Type  Injury  

Event Description

I got tested for corona virus yesterday with the nose swab thing, and since then i have been experiencing acute sinus pain from my left nostril to my left ear in a way that i can only describe as like having a pencil stuck in my head.I haven't been able to figure out if other people have experienced this.Fda safety report id# (b)(4).

• Brand Name: CORONA VIRUS NASAL TEST
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 10217482
• MDR Text Key: 197318984
• Report Number: MW5095291
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/27/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 57