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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195100
Device Problem Use of Device Problem (1670)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 07/05/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. A supplemental report will be provided after completion.
 
Event Description
The consumer reported sustaining a nasal injury while using the binaxnow covid-19 home test. The consumer reported an unspecified amount blood on the swab. (b)(6) reported that it was unclear if the consumer's nasal was swabbed twice. (b)(6) also, reported that it appeared the proctor stopped the session before any testing could take place so no actual testing occurred. However, an invalid result was reported. Although requested, no additional patient information, including treatment and outcome, was provided.
 
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Brand NameBINAX NOW COVID-19 AG CARD
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough,
ME 04074
Manufacturer Contact
erina marshall
10 southgate road
scarborough, ME 04074
MDR Report Key12257077
MDR Text Key264728062
Report Number1221359-2021-02121
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011330
UDI-Public01008118770113301721100310142400
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195100
Device Lot Number142400
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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