MAUDE Adverse Event Report: DISCUS DENTAL, LLC PHILIPS ZOOM; ZOOM CHAIRSIDE WHITENING KIT AND GEL

Model Number 22-3764

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

Patient Problems Sensitivity of Teeth (2427); Tooth Fracture (2428)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

Discus dental received a complaint on 04/10/2017, in which patient claimed in-office tooth whitening procedure caused sensitivity and a crack on occlusal surface on (b)(6) 2016.The tooth was extracted on (b)(6) 2017.The patient took amoxicillin as a medication.Reviewed complaints history of the past 3 years.No similar incident was reported.Per clinical expert assessment, no occlusal surface should be affected during the chairside whitening procedure if dfu is followed.Chairside whitening is advised on healthy teeth and it is rare for a healthy tooth to crack or chip due to a whitening procedure.Although, unless there was an undiagnosed crack or chip unrelated to the whitening, and the whitening gel exacerbated the pain and sensitivity which made the patient and dentist notice the crack on the tooth.No corrective actions are required.Dfu is adequate and it describes candidate qualification, safety directions, warnings, and precautions.Dfu states to disqualify any patient who is perio-involved, exhibits failing restorations or is otherwise in an unhealthy oral state.It also describes patients more susceptible to sensitivity are those with known hypersensitivity, untreated caries, exposed root surfaces, defective restorations, oral tissue injury, and untreated periodontal disease.With the available information, discus dental is unable to confirm the complaint and to determine the cause.The whitening kit and gel were used.

Event Description

Discus dental received a complaint on (b)(6) 2017, in which patient claimed in-office tooth whitening procedure caused tooth sensitivity and a crack on occlusal surface on (b)(6) 2016.The tooth was extracted on (b)(6) 2017.The patient took amoxicillin as a medication.

• Brand Name: PHILIPS ZOOM
• Type of Device: ZOOM CHAIRSIDE WHITENING KIT AND GEL
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• Manufacturer (Section G): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• Manufacturer Contact: sanjay patel ; 1700 a s baker ave; ontario, CA 91761 ; 9095703508
• MDR Report Key: 6549769
• MDR Text Key: 74584681
• Report Number: 1000582314-2017-00005
• Device Sequence Number: 1
• Product Code: EEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 22-3764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability