MAUDE Adverse Event Report: DENTSPLY CAVITRON TIP; SCALER, ULTRASONIC

Model Number 590330K

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/08/2018

Event Type  Injury  

Event Description

Patient was having prophy completed when cavitron tip broke and was swallowed.

• Brand Name: CAVITRON TIP
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY; york PA 17401
• MDR Report Key: 7352180
• MDR Text Key: 102917940
• Report Number: MW5075960
• Device Sequence Number: 1
• Product Code: ELC
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 590330K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2018
• 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): Required Intervention