MAUDE Adverse Event Report: STANFORD COVID-19 NASAL SWAB TEST; APPLICATOR, ABSORBENT TIPPED, STERILE

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 07/07/2020

Event Type  Injury  

Event Description

I went in for a covid test to see if i am an asymptomatic carrier.The nasal swab was jammed up so roughly and i have had extensive sinus surgery in the past.Now i have an extremely inflamed maxillary sinus and awful eye pain.These long sticks should not be used given the alternatives.Or, if they are used, they should also have a pre-test interview to inquire about previous nasal/ sinus surgery.Fda safety report id # (b)(4).

• Brand Name: STANFORD COVID-19 NASAL SWAB TEST
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 10257260
• MDR Text Key: 198496260
• Report Number: MW5095457
• Device Sequence Number: 1
• Product Code: KXG
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 52