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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 03/31/2022

Event Description

[binaxnow, product name] use for covid-19 under emergency use authorization (eua): my patient inadvertently used the binax ag drops in his eye instead of his usual eyedrop lubricant while on vacation in (b)(6).After over 1 hr and 37 minutes on either my third call or numerous emails on wait time, abbott has not responded.I have an ophthalmologist standing by in (b)(6).They request patient data rather than help.

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 14014787
• MDR Text Key: 288799833
• Report Number: MW5108753
• 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: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2022
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White