MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195160

Device Problem Use of Device Problem (1670)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported an allergic reaction with the binaxnow¿ covid-19 antigen self test swab utilized to take their sample on (b)(6) 2021.The consumer reported the swab caused his nose to be a bit itchy and maybe he had just pushed the swab hard that's why his nose is irritated.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The supplemental report is being submitted to correct the previously reported event.Technical services advised the customer that there is no chemicals on the swab that could give user any allergic reaction and that it is sterile with ethylene oxide.Technical service provided the sds to the customer.Technical services attempted to obtain additional information about customer actions and if additional medical attention was required but was unsuccessful.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.The product will continue to be monitored and tracked.

• Brand Name: BINAX NOW COVID-19 AG CARD
• 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12602914
• MDR Text Key: 279812388
• Report Number: 1221359-2021-03086
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195160
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male