MAUDE Adverse Event Report: HANDPIECE HEADQUARTERS DARBY; HANDPIECE

Model Number	SUPER TRAC PLUS PUSH BUTTON 4 HOLE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Head part of handpiece exploded inside the patient's mouth while being used during a treatment.

• Brand Name: DARBY
• Common Device Name: 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
• Report Number: 3007007357-2023-00013
• Device Sequence Number: 14140338
• Product Code: EFB
• UDI-Device Identifier: 00889813025635
• UDI-Public: 0100889813025635
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown