MAUDE Adverse Event Report: TTBIO CORPORATION PDS MAXPRO; HANDPIECE

Model Number PDS MAXPRO

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Root cause: oversight / human error from ny-prorepair which caused the defective handpiece to be returned back to the customer.

Event Description

The patient was having some treatment done requiring a handpiece, as the doctor was drilling in the patient's mouth the handpiece fell apart and numerous pieces went flying in all directions in the patients mouth and cut the inside of the patient's mouth in the lower palate.No special attention was needed.Patient was given a medicated oral rinse for some home care.No follow ups were scheduled.Patient seems to be okay, have not heard from him since the incident.

• Brand Name: PDS MAXPRO
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORPORATION; 2f., no.07; 6th industry park; taichung, 40755 ; TW 40755
• MDR Report Key: 13067756
• MDR Text Key: 282736473
• Report Number: 3010364969-2021-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDS MAXPRO
• Device Catalogue Number: 570-0687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male