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

Model Number BA250LT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Adverse event notification and handpiece was initially sent to dentsply sirona, based in (b)(4); dentsply sirona is the oem for this handpiece.Upon completing device evaluation, sirona informed us that this handpiece was distributed by ba international ltd., and indicated ba international's brand name of the product: ce label 0476.Dentsply sirona has provided their investigation report.Additionally, the handpiece will be returned back to handpiece headquarters and be readily available for ba international's evaluation.This report has also been sent to ba international.

Event Description

Dentist was performing a crown prep.At the beginning of the procedure, the female patient said something was burning her cheek.The dentist thought it might be due to them pulling her cheek.As the dentist continued to cut, the same response was given by the patient.The assistant checked the patient's cheek and verified there were two white circles on the inside near the crease/opening.The patient did not seek any medical attention.

• 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: 10833954
• MDR Text Key: 216101801
• Report Number: 3007007357-2020-00001
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BA250LT
• Device Catalogue Number: BA250LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2020
• Distributor Facility Aware Date: 10/13/2020
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other