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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195160
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. A supplemental report will be provided after completion.
 
Event Description
The user states that during testing the swab broke inside the patients nostril. The user stated that on the swab there was what looked like a marking and user thought it had to go all the way into the nostrils. The user then inhaled the broken swab. The swab was inside the user's sinus for 2 hours. The user went to the emergency room however sneezing ejected the swab out of the nose. Although attempts were made, no additional information was provided.
 
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Brand NameBINAXNOW COVID-19 HOME TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCABOROUGH
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key12444143
MDR Text Key270528280
Report Number1221359-2021-02480
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
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,Followup,Followup
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/07/2022
Device Catalogue Number195160
Device Lot Number138199
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received11/30/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/06/2021
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: 09/08/2021 Patient Sequence Number: 1
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