MAUDE Adverse Event Report: ABBOTT LABORATORIES BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 195-160

Device Problems Product Quality Problem (1506); Use of Device Problem (1670); Device Ingredient or Reagent Problem (2910)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 05/22/2021

Event Type  Injury  

Event Description

My doctor believes i have breakthrough covid-19.To be 100% sure, i purchased the binaxnow test by abbott labs.The instructions were simple and followed completely.When i opened the swab and gently put it into my nostrils to gather the sample, i immediately felt an intense burning sensation.I tried to continue, but the pain was too intense and my eyes were tearing, so i stopped.I was concerned that whatever the swab was made of or what it was sterilized with, could harm my nostrils.Since i was unable to collect a good sample, the test came up negative.Today, (b)(6), i contacted abbott technical service at (b)(4), a number in their package.The first individual was pleasant and transferred me to a technical representative giving her all my information.The rep then asked many of the same questions again without giving me any insight.I was disconnected and despite them asking for my number and email in case we did get disconnected, nobody called back.I called again.New first level rep who could not find any of my information in the computer.Started all over.She finally transferred me to a technical rep who happened to be the one who disconnected me.After much useless conversation she said to me that "abbott labs did not know what their local producer made the swabs out of nor what they used to sterilize them".How could a well-known medical company not know what their product is made from? i was quite angry and asked for a higher level employee, but they were all busy.I asked that this rep get hold of the first executive there and have he/she call me.I never expected it to happen and it hasn't.Besides the pain that i experienced and the inability to complete their covid-19 test, i had concerns that my nostrils may have been damaged by whatever caused the intense burning.In addition, i did not want another unsuspecting user to experience what i did.I think abbott acted poorly about my problem.Any medical company that would come out and say they don't know what a part of their product (a big part of this product) is made of, should raise concerns for the fda.After the incident i saw reports saying test companies were using a known carcinogen to sterilize swabs.Really fda, america has become used to substandard products, frequently from (b)(6), but medical products? i want to know that i am safe using otc and other products.Now i am not sure.I am not sure my nostrils were not hurt/contaminated with something harmful to me and others.Thank you in advance for taking this seriously and investigating.Fda safety report id #: (b)(4).

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT LABORATORIES
• MDR Report Key: 11892965
• MDR Text Key: 253125292
• Report Number: MW5101556
• Device Sequence Number: 1
• Product Code: QKP
• 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: 05/24/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2021
• Device Model Number: 195-160
• Device Lot Number: 155582
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR