MAUDE Adverse Event Report: STAR DENTAL HIGH SPEED HANDPIECE

Model Number 430SW

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/29/2016

Event Type  malfunction  

Event Description

Patient was having dental work completed when they noticed that the handpiece being used by the doctor heated up causing a burn to their cheek.

• Brand Name: HIGH SPEED HANDPIECE
• Type of Device: HIGH SPEED HANDPIECE
• Manufacturer (Section D): STAR DENTAL; lancaster PA 17601
• MDR Report Key: 5797990
• MDR Text Key: 49762117
• Report Number: MW5063439
• Device Sequence Number: 1
• Product Code: EFA
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR