MAUDE Adverse Event Report: STAR DENTAL; BUR, DENTAL

Model Number 430K

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/06/2018

Event Type  Injury  

Event Description

After adult prophy pt stated she has a sharp restoration on tooth #5 distal.Bur that was used to smooth the filling by (b)(6).Bur fell into the pt's mouth and pt was instructed not to swallow.Pt ingested bur.(b)(4).

• Brand Name: STAR DENTAL
• Type of Device: BUR, DENTAL
• MDR Report Key: 7876620
• MDR Text Key: 120456817
• Report Number: MW5079815
• Device Sequence Number: 1
• Product Code: EJL
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 430K
• 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: 26 YR