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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

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ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2 Back to Search Results
Lot Number COV1120157
Device Problem Contamination (1120)
Patient Problem Burning Sensation (2146)
Event Date 01/28/2022
Event Type  Injury  
Event Description
Acon was made aware of the complaint via customer call on (b)(6) 2022 regarding a potential injury from the flowflex covid-19 antigen home test. The customer informed acon that she and her husband experienced burning sensation from the use of sample swabs included with the test kit, and a foaming reaction occurred when they tried to rinse out the nostril with saline solution. Per the complaint, it was unknown whether the sample swabs were contaminated before or after taken out of the sterile packaging. No further information about patient condition was available at the time of this mdr. The l/n of the test kit and the retention lot is available for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
Acon was made aware of the complaint via customer call on (b)(6) 2022 regarding a potential injury from the flowflex covid-19 antigen home test. The customer informed acon that she and her husband experienced burning sensation from the use of sample swabs included with the test kit, and a foaming reaction occurred when they tried to rinse out the nostril with saline solution. Per the complaint, it was unknown whether the sample swabs were contaminated before or after taken out of the sterile packaging. No further information about patient condition was available at the time of this mdr. The l/n of the test kit and the retention lot is available for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
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Brand NameFLOWFLEX COVID-19 ANTIGEN HOME TEST
Type of DeviceANTIGEN DIAGNOSTIC FOR SARS-COV-2
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 Key13500501
MDR Text Key285711145
Report Number2531491-2022-00001
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberCOV1120157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2022
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: 02/09/2022 Patient Sequence Number: 1
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