MAUDE Adverse Event Report: HANDPIECE HEADQUARTERS DARBY; HANDPIECE

Model Number SUPER TRAC PLUS PUSH BUTTON 4 HOLE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  Injury  

Event Description

Head part of handpiece exploded inside the patient's mouth while being used during a treatment.

• Brand Name: DARBY
• Type of Device: HANDPIECE
• 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: 18414598
• MDR Text Key: 331581798
• Report Number: 3007007357-2023-00013
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00889813025635
• UDI-Public: 0100889813025635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/28/2023

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: SUPER TRAC PLUS PUSH BUTTON 4 HOLE
• Device Catalogue Number: 9430028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other