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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 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 AG CARD CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 195-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Contact Dermatitis (4546)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. A supplemental report will be provided after completion.
 
Event Description
The customer reported that the nurse performing the binaxnow covid-19 ag card first applied drops to top well and then inserted swab into bottom well and pushed up into reagent, prior to removing swab from test card and then swabbing the patient's nasal nares. The msds was sent to the customer and the patients nasal nares were then flushed with saline. The customer states the patient experienced inflammation in nasal nares and emotional distress. The customer states there was serious injury related to the event and no medical treatment was required.
 
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Brand NameBINAXNOW COVID-19 AG CARD
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, ME 04074
6613888803
MDR Report Key12973097
MDR Text Key283685661
Report Number1221359-2021-03710
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-000
Device Lot Number167113
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2021 Patient Sequence Number: 1
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