MAUDE Adverse Event Report: ULTRASONIC SCALER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tinnitus (2103); Discomfort (2330)

Event Date 02/14/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, my teeth were cleaned by a hygienist who used an ultrasonic descaler.During ultrasonic cleaning, i experienced a brief but severe sharp pain in my right ear where the descaler was used on a left lower molar.I experienced discomfort throughout the cleaning in the area where the descaler was being used in my mouth.Since the cleaning, i have had severe high pitch tinnitus in my right ear continually.I also have ongoing soreness and pain in the area where the descaler was used in my mouth in both the upper and lower jaw.I was not informed that there were any risks from ultrasonic teeth cleaning.I am worried that the tinnitus will be permanent as a month has already gone by without any improvement.

• Brand Name: ULTRASONIC SCALER
• Type of Device: ULTRASONIC SCALER
• MDR Report Key: 6420323
• MDR Text Key: 70583046
• Report Number: MW5068548
• Device Sequence Number: 1
• Product Code: ELC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/17/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 90