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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR ¿ AT-HOME COVID-19 TEST NOT CLASSIFIED

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BECTON, DICKINSON & CO. (SPARKS) BD VERITOR ¿ AT-HOME COVID-19 TEST NOT CLASSIFIED Back to Search Results
Catalog Number 256094
Device Problem Leak/Splash (1354)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. Initial reporter: address unavailable. Bd corporate address used. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It has been reported that while testing with the bd veritor ¿ at-home covid-19 test, an allergic reaction occurred due to exposure. The following has been provided by the initial reporter: it was reported by the customer that they experienced an itchy throat and coughing after spilling a test component on their hand. ¿not sure if i accidentally inhaled the test tube liquid because it spilled a little on my hand when i opened it. I¿m coughing and my throat is a little itchy. ¿.
 
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Brand NameBD VERITOR ¿ AT-HOME COVID-19 TEST
Type of DeviceNOT CLASSIFIED
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13296441
MDR Text Key284308394
Report Number1119779-2022-00061
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number256094
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/19/2022 Patient Sequence Number: 1
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