MAUDE Adverse Event Report: ACCESS BIO INCORPORATE COVID 10 HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number CP22K09

Patient Problem Foreign Body In Patient (2687)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

This is regarding a covid test supplied by usps.The nasal swab is fragile and broke while swabbing my nose.The swab was so short i had to pull it out with tweezers.Carestart covid-19 home test lot cp22k09, exp 2024-01-28.

• Brand Name: COVID 10 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACCESS BIO INCORPORATE
• MDR Report Key: 18365642
• MDR Text Key: 331078514
• Report Number: MW5149412
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2024
• Device Lot Number: CP22K09
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Patient Sequence Number: 1
• Treatment: ALLEGRA; LEXAPRO ; OMEPRAZOLE
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White