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

Model Number	881055601540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2017 in which patient had an allergic reaction and broke out in hives during in-office teeth whitening procedure.No pain or injury in the mouth or lips was reported.The patient took benadryl and was referred to see an allergist by her dentist.No information was provided if the patient visited a specialist or not.The dentist mentioned that the patient appeared itchy and uncomfortable before starting the procedure.The hives were cleared up within the next day.Investigation: - the product was used up during the procedure and not available for return.- the retain sample of the zoom whitening gel, (b)(4), lot: 17158007 was tested on 9/13/2017 and results were within specifications.- reviewed device history records of zoom whitening kit, (b)(4), lot: 17131017, zoom whitening gel, (b)(4), lot: 17158007 and no out of specification was found in the records.- reviewed receiving records and certificate of analysis of liquidam and no out of specification was found.- reviewed complaints history, no other similar incidents were reported from the same lots.- reviewed direction for use of the kit.The dfu describes candidate qualification, warnings, ingredients, and other precautions.Product labeling also includes ingredients list.- potential cause of this event may be an allergic reaction to one of the product ingredients.Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product.Product was used up during the procedure.
Event or Problem Description
Discus dental received a complaint on (b)(6) 2017 in which patient had an allergic reaction and broke out in hives during in-office teeth whitening procedure.No pain or injury in the mouth or lips was reported.The patient took benadryl and was referred to see an allergist by her dentist.No information was provided if the patient visited a specialist or not.The dentist mentioned that the patient appeared itchy and uncomfortable before starting the procedure.The hives were cleared up within the next day.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE WHITENING KIT AND GEL
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• MDR Report Key: 6914176
• Report Number: 1000582314-2017-00008
• Device Sequence Number: 1312594
• Product Code: EEG
• UDI-Device Identifier: 00075020034991
• UDI-Public: (01)00075020034991(10)17131017(17)190314
• 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: Dental Assistant
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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: 03/14/2019
• Device Model Number: 881055601540
• Device Lot Number: 17131017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/04/2017
• 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