MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 195160

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Epistaxis (4458)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The user reported she has performed (4) binaxnow¿ covid-19 antigen self tests but when she swabs her nostrils it causes a nose bleed.The user reports the swab is saturated with blood.The user reported that the swab was inserted 1/2 inch into the nostril.The user statesthat the blue control line on the binaxnow¿ covid-19 antigen self test disappears after the test is performed.The user went to a medical professional and the user explained what happened.The user reported that the medical professional was not sure why the swabs was causing the nose bleeds.The medical professional stated the swabs did not cause any medical issues.

Manufacturer Narrative

A product deficiency was not identified and no further action is required.Based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAX NOW COVID-19 AG CARD
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• 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: 12719106
• MDR Text Key: 279001456
• Report Number: 1221359-2021-03363
• 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: 05/04/2022

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: 195160
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/05/2022
• 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: Female