MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC CAVITRON TIP; SCALER, ULTRASONIC

Model Number UI30SD100

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/06/2017

Event Type  Injury  

Event Description

Patient was having scaling down by dental hygienist when tip of cavitron broke and patient swallowed.Sent for chest x-ray to verify that it had not been aspirated.

• Brand Name: CAVITRON TIP
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; chicago IL 60618
• MDR Report Key: 7112112
• MDR Text Key: 94867432
• Report Number: MW5073937
• 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
• Type of Report: Initial
• Report Date: 12/11/2017

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: UI30SD100
• Device Catalogue Number: UI30SD100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• 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
• Patient Age: 71 YR