MAUDE Adverse Event Report: STAR DENTAL STAR DENTAL/DENTALEZ GROUP; HANDPIECE

Model Number 460 SW

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2017

Event Type  Injury  

Event Description

Dentist was treating patient when bur came out of the handpiece and might have been swallowed or aspirated.

• Brand Name: STAR DENTAL/DENTALEZ GROUP
• Type of Device: HANDPIECE
• Manufacturer (Section D): STAR DENTAL; lancaster PA 17601
• MDR Report Key: 6493000
• MDR Text Key: 72917340
• Report Number: MW5069079
• Device Sequence Number: 1
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/12/2017

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: 460 SW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR