MAUDE Adverse Event Report: HANDPIECE HEADQUARTERS MIDWEST; TURBINE

Model Number MIDWEST STYLUS MINI 540S/ 541S PB

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2023

Event Type  Injury  

Event Description

A diamond bur shot out of the handpiece while in use, resulted to patient swallowing bur and being sent to the hospital for a procedure to remove bur.

• Brand Name: MIDWEST
• Type of Device: TURBINE
• Manufacturer (Section D): HANDPIECE HEADQUARTERS; 620 s. placentia ave.; placentia CA 92870
• Manufacturer (Section G): HANDPIECE HEADQUARTERS; 620 s. placentia ave.; placentia CA 92870
• Manufacturer Contact: frederick wang ; 620 s. placentia ave.; placentia, CA 92870 ; 7145790175
• MDR Report Key: 16588530
• MDR Text Key: 311734197
• Report Number: 3007007357-2023-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/21/2023

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: MIDWEST STYLUS MINI 540S/ 541S PB
• Device Catalogue Number: HMW851-HHC47
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention