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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Catalog Number 195-100
Device Problem Use of Device Problem (1670)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 08/03/2022
Event Type  Injury  
Event Description
The consumer reported having a severe allergic reaction to foamtech medical nasal swab from binaxnow covid-19 ag home test. The patient reported a very painful reaction upon inserting the swab into their nose. The patient reportedly experienced a tingling feeling that developed into an intense burning sensation in the throat. Intense additionally, the pain caused the patient to heave. The patient reportedly went to the emergency room after completing the test. The patient had no known allergies and did not conduct any allergic testing. The patient reportedly uses a nasal spray daily. Although requested, details of the emergency room visit were not provided.
 
Manufacturer Narrative
This report is being submitted for the initial and investigation completion. Technical services advised the customer to seek medical attention if the allergic reaction proceeds. Technical services emailed the customer the foamtech medical safety data sheet. Technical services provided the customer the detailed methodology for the sterilization processes of the kit swabs. The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.
 
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Brand NameBINAXNOW COVID-19 AG CARD HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough,
ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough,
MDR Report Key15283713
MDR Text Key298491522
Report Number1221359-2022-04298
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011330
UDI-Public01008118770113301722122110178674
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA203107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-100
Device Lot Number178674
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/24/2022 Patient Sequence Number: 1
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