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

Model Number ZM2666

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The incident was occurred in (b)(6).Thus gel and kit were used, and not available to be returned.The retain samples of whitening gels from the same lots were tested on (b)(6) 2016, and results were within specifications.Device history record of whitening gel and whitening kit were reviewed, and no out of specifications or discrepancy was found.Reviewed the bill of materials and instructions for use.Dfu describes the steps for proper isolation of gums and lips.Warning notes are also included in the product packaging.Reviewed complaints history of the past 3 years, and no other similar complaints were received with similar symptoms.Discus dental concludes that no malfunction or failure is detected in the device.The cause of this incident, as described in complaint description, is failure to follow the instructions provided with the product.Discus dental will continue to monitor similar complaints.The whitening kit and gel were used.

Event Description

Discus dental received the complaint on 7/25/2016, in which the patient received a zoom in-office whitening procedure in (b)(6) 2016.The hygienist who performed the whitening did not follow the whitening protocol, and did not cover the patient's gingiva.Thereafter the patient experienced swollen gums.The patient visited a doctor, and they performed colonoscopies, and prescribed vicodin and motrin.The patient is also experiencing bone density loss in the same area where the gums were swollen.

• 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: 5895310
• MDR Text Key: 52721099
• Report Number: 1000582314-2016-00007
• Device Sequence Number: 1
• Product Code: EEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Expiration Date: 08/31/2016
• Device Model Number: ZM2666
• Device Lot Number: 15196003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other