MAUDE Adverse Event Report: STAR DENTAL 430SW HAND PIECE

Model Number 430 SW

Device Problem Overheating of Device (1437)

Patient Problem Swelling (2091)

Event Date 01/04/2018

Event Type  malfunction  

Event Description

Pt was having procedure done when the hand piece is alleged to have warmed up enough to turn the pt's lip and caused a blister.

• Brand Name: 430SW HAND PIECE
• Type of Device: 430SW HAND PIECE
• Manufacturer (Section D): STAR DENTAL; lancaster PA 17601
• MDR Report Key: 7202987
• MDR Text Key: 97782718
• Report Number: MW5074640
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430 SW
• 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: 71 YR