MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON JET PLUS; ULTRASONIC SCALER

Model Number G132

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Tinnitus (2103); Vertigo (2134); Dizziness (2194); Disability (2371)

Event Date 09/19/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, a pt reported that they had ear pain and dizziness afer undergoing a dental treatment with a cavitron jet plus unit that was reported as "loud." because there was not enough info present in the original report to reasonably suggest that the device caused or contributed to a serious injury, it was not considered to be reportable.On (b)(6) 2014, dentsply received a maude report from fda with additional info pertaining to this event.The pt had seen an otolaryngologist and was diagnosed with benign paroxysmal positional vertigo (bppv).

Manufacturer Narrative

Therefore, because this event is associated with a serious injury, it meets the criteria of a reportable event in the u.S.Per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

• Brand Name: CAVITRON JET PLUS
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; york PA
• Manufacturer Contact: helen lewis ; 221 w. philadelphia street, suite 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 3690558
• MDR Text Key: 4302495
• Report Number: 2424472-2014-00002
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G132
• Device Catalogue Number: G132
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HUE-FRIEDY INSERTS
• Patient Outcome(s): Disability