MAUDE Adverse Event Report: DENTALEZ, INC. STARDENTAL; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number NRS2

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2023

Event Type  malfunction  

Event Description

As the dentist was using the slow speed drill, the dentist noticed a metal piece in the child¿s mouth.The dentist retrieved the metal piece out of the patient¿s mouth and no harm was brought to the patient.The drill was replaced by this rn.

• Brand Name: STARDENTAL
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): DENTALEZ, INC.; 1816 colonial village ln; lancaster PA 17601
• MDR Report Key: 18139639
• MDR Text Key: 328157388
• Report Number: 18139639
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NRS2
• Device Lot Number: 44M9
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1