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

Model Number BA250LT

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

On 04/22/21, ba international responded: 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 (b)(6) is kindly following up on obtaining further information surrounding the specific details of the events.

Event Description

In the process of cutting off the crown (crown removal procedure), the head of the handpiece rested on the top of the patient's tongue.After continuing cutting for 20-30 seconds, doctor noticed tongue turning white.Doctor suggested saltwater rinse.No follow-up treatment was pursued.

• Brand Name: BA INTERNATIONAL 1:5 HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): BA INTERNATIONAL LTD.; unit 9, kingsthorpe business; centre, studland road,; kingsthorpe, northampton NN2 6 NE; UK NN2 6NE
• MDR Report Key: 11734659
• MDR Text Key: 260437299
• Report Number: 3007007357-2021-00001
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• 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: 58 YR