MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number REF 195-100

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

Patient Problems Burning Sensation (2146); Epistaxis (4458)

Event Date 03/29/2022

Event Type  Injury  

Event Description

Intense burning sensation in nasal membranes and nose bleed.Fda safety report id #: (b)(4).

• Brand Name: BINAXNOW COVID-19 AG CARD HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13965410
• MDR Text Key: 288360544
• Report Number: MW5108624
• 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: 03/29/2022

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 Expiration Date: 01/02/2023
• Device Model Number: REF 195-100
• Device Catalogue Number: BOX DOESN'T SPECIFY
• Device Lot Number: 180107
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2022
• Patient Sequence Number: 1
• Treatment: VITAMIN C; VITAMIN D3
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White