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

Model Number	881055601540
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on 04/27/2018 in which patient experienced swollen lips after in-office zoom teeth whitening procedure.Dentist stated that he used a winged retractor and not the retractor provided with the zoom chairside kit.Patient has been icing lip and took benadryl.Dentist stated that the patient visited a physician and received medication, however, the patient did not disclose the type of medication.Investigation: - the retain sample of the in-office whitening gel, sku: (b)(4), lot: 18093003 was tested on 04/27/2018 and results were within specifications.- 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.Based on the information provided by the dentist, potential causes may be not using the retractor provided with the chairside whitening kit.Zoom in-office dfu is adequate and it describes the warnings and precautions, steps for proper lip isolation, and the necessity to use the isoprep retractor provided with the kit.Based on the 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 (b)(6) 2018 in which patient experienced swollen lips after in-office zoom teeth whitening procedure.Dentist stated that he used a winged retractor and not the retractor provided with the zoom chairside kit.Patient has been icing lip and took benadryl.Dentist stated that the patient visited a physician and received medication, however, the patient did not disclose the type of medication.

• 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: 7546497
• Report Number: 1000582314-2018-00002
• Device Sequence Number: 18876297
• Product Code: EEG
• UDI-Device Identifier: 00075020034991
• UDI-Public: (01)00075020034991(10)118096010(17)200103
• 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): 05/25/2018

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: Dentist
• Device Expiration Date: 01/03/2020
• Device Model Number: 881055601540
• Device Lot Number: 18096010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• 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