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

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	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(4) 2018, in which the patients face began to swell after a zoom chairside whitening procedure.The patient also developed numbness and swelling of her lower lip.The patient went to urgent care and was given dexamethasone injection, 3 doses of benadryl and was prescribed 20mlg prednisone.The kit and gel were used up during the procedure and were not returned.The retain sample of the whitening gel, sku: 22-3764, lot: 18165002, was tested on 08/31/2018, and results were within specifications.Reviewed the device/batch history records of whitening kit, sku: 881055601540, lot: 18165003 and gel, sku: 22-3764, lot: 18165002.No out of specification or discrepancy was found.Reviewed complaints history, no other similar incident was reported from the same lot numbers.Reviewed complaints history of the past 3 years.The rate for similar incidents is low.Reviewed direction for use of the kit.The dfu describes steps for candidate qualification, warnings, ingredients, and other precautions.All ingredients are listed on labeling.No product failure or out of specifications was found in the product.Potential cause may be an allergic reaction to product ingredients.Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product.No corrective actions are required.Patient is doing much better, the swelling is gone and she is fine.
Event or Problem Description
Discus dental received a complaint on (b)(4) 2018, in which the patients face began to swell after a zoom chairside whitening procedure.The patient also developed numbness and swelling of her lower lip.The patient went to urgent care and was given dexamethasone injection, 3 doses of benadryl and was prescribed 20mlg prednisone.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700a south baker ave.; ontario CA 91761
• MDR Report Key: 7900055
• Report Number: 1000582314-2018-00005
• Device Sequence Number: 16214512
• Product Code: EEG
• UDI-Device Identifier: 00075020034991
• UDI-Public: (01)00075020034991(10)18165003(17)200404
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: 881055601540
• Device Lot Number: 18165003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/21/2018
• 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