MAUDE Adverse Event Report: NASOPHARYNGEAL SWAB; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

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

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tinnitus (2103); Burning Sensation (2146); Impaired Healing (2378)

Event Date 07/09/2020

Event Type  Injury  

Event Description

Hi, i would like to know what, if any, data you have on the dangers of repeated nasopharyngeal swabbing.My employer recently announced mandatory weekly nasopharyngeal swab covid19 testing, and i am experiencing issues after swab #2.Research indicates that the nasopharynx needs 3-4 weeks to regenerate cells from scraping so doing this weekly isn't allowing for proper healing time in between tests.My first swab wasn't bad, but 2nd one was way worse.The whole inside of my tested nostril (the left) immediately burned, it started bleeding around 11am (i tested around 8:30), it's been steadily runny ever since, my left ear has been ringing, i have a raging migraine deep within that neither acetaminophen nor ibuprofen tackles and my left eye is sleepy and droopy.I can still feel the spot where the bristle hit the back of my nasopharynx.I did have a headache all day with the first one too, which i read is common, but it wasn't super bad like this time.I tried researching repeated covid testing and problematic testing on deviated septums to see if anyone has experienced similar issues, but found nothing.Don't know that many folks have repeated these weekly long enough to gather any interesting data.I do know it obviously isn't normal to jam things up our noses regularly and i'm wondering what kind of junk is pushed up there along with the test device.Whatever was in my nose, like pollens, dust or whatever, probably got pushed up in there too.We have nose hairs and mucous for good reason, after all; i had an ent appointment and dr confirmed i have an infection in my eye, ear, and nasal cavity as a result of the swab test and am taking antibiotic and steroid to combat.We hope this heals, otherwise i will have to have an exploratory scope to see about any permanent damage.Please let me know what you are finding.I think this is important to understand.Thank you.(b)(6).Fda safety report id# (b)(4).

• Brand Name: NASOPHARYNGEAL SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 10282481
• MDR Text Key: 199250980
• Report Number: MW5095536
• Device Sequence Number: 1
• Product Code: KXF
• 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: 07/14/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 59