MAUDE Adverse Event Report: STAR DENTAL STAR DENTAL; DRILL, DENTAL

Model Number 430SW

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/18/2017

Event Type  malfunction  

Event Description

The patient accidentally swallowed a small hand piece bur.Dr.(b)(6) who was doing the procedure explained to the patient what had happened.Charted the incident in her chart and instructed the patient to be aware if anything were to pass through her system.Dr.(b)(6) would like the patient to have an x-ray done just to make sure it passed through her system.

• Brand Name: STAR DENTAL
• Type of Device: DRILL, DENTAL
• Manufacturer (Section D): STAR DENTAL; lancaster PA 17601
• MDR Report Key: 6843344
• MDR Text Key: 84959208
• Report Number: MW5071955
• Device Sequence Number: 1
• Product Code: NDP
• 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: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• 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: 28 YR