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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameBINAXNOW
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key12638609
MDR Text Key276859719
Report NumberMW5104630
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number14D2184926
Device Lot Number152120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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