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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
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ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Burning Sensation (2146)
Event Date 10/05/2022
Event Type  Injury  
Event Description
End user reported burning irritation in her nostril after performing swab extraction.The user verified there was no extraction buffer on the swab before swabbing her nostril, and the swab was sealed in its packaging prior to swabbing.No medical assistance was received by the user.
 
Manufacturer Narrative
In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.The following fields are updated: b4, "date of this report" - date of follow-up report.G6, "type of report" - follow-up #1.H2, "if follow-up, what type?" - updated to "additional information." h6 "adverse event problem" - event problem and evaluation codes such as "investigation findings" and "investigation conclusions" are added per investigation.H10 "additional narrative/data" - added manufacturer's narrative.
 
Event Description
End user reported burning irritation in her nostril after performing swab extraction.The user verified there was no extraction buffer on the swab before swabbing her nostril, and the swab was sealed in its packaging prior to swabbing.No medical assistance was received by the user.
 
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Brand Name
FLOWFLEX COVID-19 ANTIGEN HOME TEST
Type of Device
ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
Manufacturer (Section D)
ACON LABORATORIES, INC.
5850 oberlin drive #340
san diego CA 92121
Manufacturer (Section G)
ACON LABORATORIES, INC.
5850 oberlin drive #340
san diego CA 92121
Manufacturer Contact
qiyi xie
5850 oberlin drive #340
san diego, CA 92121
8588758011
MDR Report Key15620906
MDR Text Key301904698
Report Number2531491-2022-00012
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
EUA210494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/05/2022
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 Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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