MAUDE Adverse Event Report: ACCESS BIO INCORPORATE ON GO COVID ANTIGEN SELF TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number CP21L59

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/09/2022

Event Type  Injury  

Event Description

Swab broke and was lodged in the child's nose (which had to be removed by a pediatric ent as an emergency).Fda safety report id # (b)(4).

• Brand Name: ON GO COVID ANTIGEN SELF TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACCESS BIO INCORPORATE
• MDR Report Key: 14397105
• MDR Text Key: 291739024
• Report Number: MW5109665
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/10/2022

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?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Lot Number: CP21L59
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 14 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White