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 Codes	Reaction (2414); Sensitivity of Teeth (2427)
Date of Event	06/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2017, in which patient initially experienced pain during zoom in-office teeth whitening procedure.Ten minutes later, hives appeared on patient's face, back and arms.Steroids were prescribed by the medical doctor.The patient was feeling better 2 days after the event and was healed one week after the incident.Investigation: the kit and gel were used up during the procedure and were not returned.Reviewed complaints history, no other similar incident was reported from the same lot numbers.Reviewed the device/batch history records of gel, sku: (b)(4), lot: 17030021, zoom whitening kit, sku: (b)(4), lot: 17040011, udi: (b)(4), and zoom whitespeed lamp, sku: (b)(4), sn: (b)(4).No out of specification or discrepancy was found.The retain sample of the whitening gel, sku: (b)(4), lot: 17030021, was tested on 07/20/2017, and results were within specifications.Reviewed direction for use of the kit.The dfu describes candidate qualification, warnings, ingredients, treat for tooth sensitivity, and other precautions.A potential cause for hives breakout would be an allergic reaction to one of the product ingredients.In addition, as described in dfu, pre-existing tooth sensitivity may have contributed to the pain and sensitivity experienced during the procedure.Based on the investigation results and available information, discus dental concludes there was no product failure or malfunction.The whitening kit and gel were used up.
Event or Problem Description
Discuss dental received a complaint on (b)(6) 2017, in which patient initially experienced pain during zoom in-office teeth whitening procedure.Ten minutes later, hives appeared on patient's face, back and arms.Steroids were prescribed by the medical doctor.The patient was feeling better 2 days after the event, and was healed one week after the incident.

• 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: 6734079
• Report Number: 1000582314-2017-00007
• Device Sequence Number: 724984
• Product Code: EEG
• UDI-Device Identifier: 00075020034991
• UDI-Public: (01)00075020034991(10)17040011(17)181205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 07/21/2017

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: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: 881055601540
• Device Lot Number: 17040011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/21/2017
• 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