MAUDE Adverse Event Report: DENTALEZ INC, STARDENTAL DIVISION STAR DENTAL; HANDPIECE

Model Number 430SW

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

Patient swallowed a finishing bur that came out of a hand piece.

• Brand Name: STAR DENTAL
• Type of Device: HANDPIECE
• Manufacturer (Section D): DENTALEZ INC, STARDENTAL DIVISION
• MDR Report Key: 7285635
• MDR Text Key: 100695871
• Report Number: MW5075380
• Device Sequence Number: 0
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430SW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 70 YR