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

Model Number ZM2665

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

The patient went through a zoom teeth whitening procedure at dental office on (b)(6) 2016.The patient reported this incident on (b)(6) 2016, and described she suffered severe swelling, second degree burns, blistering, and bleeding lips.The patient stated that she was not able to go to work for two weeks, and she visited medical doctors for treatments.She was prescribed antibiotic topical gel and steroid cream.Device history records of (b)(4) zoom whitening gel, lot # 15343006 and zm2665 zoom whitening kit, lot # 15337007 were reviewed.The review of the device history records did not uncover any out of specification condition or adverse finding.In addition, the retain sample of the whitening gel, lot # 15343006 was tested on 06/29/2016.The results were within specifications.No other quality issue was found during the review of the records.Customer complaint log from (b)(6) 2015 to (b)(6) 2016 was reviewed.No other safety incident was reported with the same lot numbers.Labeling and direction for use were reviewed.The dfu is adequate, and it describes precautions, isolation, whitening procedure, and steps to sooth tissue.Based on the investigation and information available, no malfunction, failure, or out of specification was found in the product.Improper isolation prior to the procedure may have caused this event.Discus dental will continue to monitor complaints.The whitening kit and gel were used.

Event Description

The patient went through a zoom teeth whitening procedure at dental office on (b)(6) 2016.The patient reported this incident on (b)(6) 2016, and described she suffered severe swelling, second degree burns, blistering, and bleeding lips.The patient stated that she was not able to go to work for two weeks, and she visited medical doctors for treatments.She was prescribed antibiotic topical gel and steroid cream.

• Brand Name: PHILIPS ZOOM
• Type of Device: ZOOM CHAIRSIDE WHITENING KIT
• 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 south baker ave; ontario, CA 91761 ; 9095703537
• MDR Report Key: 5817608
• MDR Text Key: 50291861
• Report Number: 1000582314-2016-00006
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 01/28/2017
• Device Model Number: ZM2665
• Device Lot Number: 15337007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other