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

Model Number	ZM2666
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on 12/21/2017 in which patient's upper and lower lips were burned after in-office zoom teeth whitening procedure.The dentist stated that the patient did not have the four (4) front teeth, and the retractor did not fit in the patient's mouth.Dental hygienist used goggles to cover the lips during the whitening procedure.No information was provided if medical treatment was required after the incident.Investigation: - the retain sample of the in-office whitening gel, sku: (b)(4), lot: 16035011 was tested on 01/02/2018 and results were within specifications.- reviewed device history records of zoom whitening kit, sku: (b)(4), lot: 16043036, and whitening gel, sku: (b)(4), lot: 16035011 and no out of specification or discrepancy was found in the records.The bill of material shows that 2 retractors with standard and small sizes were provided with the kit.- reviewed direction for use provided with the device.Dfu describes the warnings and precautions and steps for proper lip isolation - reviewed complaints history, no other similar incidents were reported with the same lot numbers.- based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device.Potential causes may be improper lips isolation prior to the procedure and not following the instructions provided in the dfu.Based on the complaint description and investigation results, no product failure and out of specification was found.Dfu is adequate and no corrective action is needed.Product was used up during the procedure.
Event or Problem Description
Discus dental received a complaint on 12/21/2017 in which patient's upper and lower lips were burned after in-office zoom teeth whitening procedure.The dentist stated that the patient did not have the four (4) front teeth, the retractor did not fit in the patient's mouth, and the dental hygienist used goggles to cover the lips during the whitening procedure.No information was provided if medical treatment was required after the incident.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE WHITENING KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• MDR Report Key: 7202588
• Report Number: 1000582314-2018-00001
• Device Sequence Number: 13746751
• Product Code: EEG
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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
• Operator of Device: Dental Hygienist
• Device Expiration Date: 03/27/2017
• Device Model Number: ZM2666
• Device Lot Number: 16043036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other