MAUDE Adverse Event Report: SWAB TEST; APPLICATOR, ABSORBENT TIPPED, STERILE

Device Problem Product Quality Problem (1506)

Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Reaction (2414)

Event Date 07/20/2020

Event Type  Injury  

Event Description

I live in (b)(6).I filled out an online entry form for our local urgent care.I answered all the questions asked while checking the box asking if i wanted a covid test done, no.I was asked again if i wanted said covid test, again i replied no.I actually asked for a flu test in the teleconference call with the nurse practitioner working that day.He said he needed to test me for covid because i showed active symptoms.Fever and fatigue was all i had at the time.I again ask for a flu test knowing my body.I'm a (b)(6) year old man who knows his body better than most.Against my better judgements, i proceed to the outside waiting area of said urgent care and let them know i've arrived.After the practitioner and i chat for awhile, he administers said covid test on me and my girlfriend.We proceed home.This was approximately 10:30-11:00 on (b)(6) sunday, and (b)(6) by 4:15 that same day, i developed a rash across my chest along with itching and burning forearms and legs.These symptoms continued through monday the (b)(6).I called the same urgent care again and explain my symptoms have now changed.I'm having an allergic reaction to the swab test done for covid.No explanation was given for the reaction and they really weren't sure why i was having a reaction.Again i ask for a flu test and am told it wasn't needed because influenza hasn't been seen this year.I don't buy it at this point but whatever.I get my new scripts for a form of benadryl and steroids to deal with said reaction.Again, a rash in different spots but mainly across my chest, burning and itching of my forearms and my legs."don't know, doctor had them pre." fda safety report id# (b)(4).

• Brand Name: SWAB TEST
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 10325841
• MDR Text Key: 200603923
• Report Number: MW5095709
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 79