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

Catalog Number 195-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Epistaxis (4458)

Event Date 03/29/2022

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 293651715
• Report Number: 1221359-2022-02399
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301723010210180107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 195-100
• Device Lot Number: 180107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other