MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number	195160
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Technical service advised the user to contact her doctor or the contact information provider so they can best advise her on what to do next.The user was sent the safety data sheet (sds) via email.
Event or Problem Description
The user reoported she got (2) two drops of the reagent solution on her hand and has a small red spot that's a bit irritated.The user reported she has already washed and rinsed her hand multiply times but she did not do it immediately.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
A product deficiency was not reported or identified.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any medical advice is needed.A supplemental report will be provided if any additional is obtained.

• Brand Name: BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK
• Common Device Name: LATERAL 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,; 2077305750
• MDR Report Key: 13092827
• Report Number: 1221359-2020-03873
• Device Sequence Number: 11775887
• Product Code: QKP
• UDI-Device Identifier: 00811877011415
• UDI-Public: 01008118770114151722032310160130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 195160
• Device Lot Number: 160130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female