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

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Pain (1994); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 12/26/2021

Event Type  Injury  

Event Description

I mistook the binaxnow reagent drops for eye drops and administered them into my eye.I had only recently learned earlier this week that i have dry eyes and my doctor recommended that i start using single use eye drops to alleviate the dryness.The container in the binaxnow test looks just like the otc eye drops i buy.There was no labeling to indicate what the package was.I suffered severe burning in both eyes as well as redness for several hours.Flushing the eyes with water was also painful.After reading another adverse event about this same problem where the user sought medical treatment but the doctor said that nothing was needed, i opted to wait and see if the pain subsided.At the very least, abbott needs to be labeling these vials clearly so that this doesn't continue to happen.Fda safety report id# (b)(4).

• Brand Name: BINAXNOW COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13110614
• MDR Text Key: 282967621
• Report Number: MW5106306
• Device Sequence Number: 1
• Product Code: QKP
• 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: 12/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White