MAUDE Adverse Event Report: B.A. INTERNATIONAL LTD. BA INTERNATIONAL 1:5 HANDPIECE

Model Number BA250LT

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

On 04/22/2021, (b)(4) responded with: the current understanding, is that the issue is customer misuse, and to date, there is no report of life changing injury or medical intervention.The devices are currently on route to the oem for full technical investigation as part of the root cause analysis report to ensure that there was no fault of the products and frederick is kindly following up on obtaining further information surrounding the specific details of the events.

Event Description

In the process of prepping the teeth (filling on posterior teeth operation), the top of the handpiece was touching the patient's cheek for 20 seconds and it burned the tissue.Doctor suggested saltwater rinse.The patient had a follow-up treatment on (b)(6) 2021 and the burn site had healed.

• Brand Name: BA INTERNATIONAL 1:5 HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): B.A. INTERNATIONAL LTD.; unit 9, kingsthorpe business; centre, studland road,; kingsthorpe,, northampton NN2 6 NE; UK NN2 6NE
• MDR Report Key: 11734649
• MDR Text Key: 260437478
• Report Number: 3007007357-2021-00002
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BA250LT
• Device Catalogue Number: BA250LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2021
• Distributor Facility Aware Date: 04/12/2021
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR