MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number	195-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Epistaxis (4458)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.The initial reporter elected not to be identified, therefore, no further event details are available.
Event or Problem Description
The customer reported an intense burning sensation in the nasal mebrane and a nose bleed via medwatch (b)(4).No further information was available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.A product deficiency was not reported or found.Technical service was unable to provide the relevant safety data sheet (sds).A supplemental report will be provided if any additional information is obtained.

• Brand Name: BINAXNOW COVID-19 HOME TEST
• 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: rachel blackwell ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 14274592
• Report Number: 1221359-2022-02399
• Device Sequence Number: 5842659
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301723010210180107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 195-100
• Device Lot Number: 180107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown