MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 14D2184926

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Headache (1880); Itching Sensation (1943); Burning Sensation (2146); Discomfort (2330); Numbness (2415); Nasal Obstruction (2466)

Event Date 10/12/2021

Event Type  Injury  

Event Description

Have been receiving weekly nasal swabs for c19 for 7 weeks now.Had adverse reactions to the first 6, which are summarized in a separate report.This report is for the 7th swab, received today ((b)(6) 2021).Swab has typically been dry prior to administration.Swab was noticeably damp this time.Noticed immediate nasal congestion followed by intense sinus headaches, itching and burning at the point of contact, and numbness in the upper nasal passage.Much more uncomfortable than previous adverse reactions to the swab.Performed by (b)(6), clia # 14d2184926, lot # 152120.Fda safety reported id# (b)(4).

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12638609
• MDR Text Key: 276859719
• Report Number: MW5104630
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14D2184926
• Device Lot Number: 152120
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 70