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	Patient Problem/Medical Problem (2688)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2020 in which a patient who did the whitening on friday (b)(6) 2020 and after the whitening, he experienced certain effects like chill, shaking and fatigue.The following day, these symptoms were gone.However, started to have herpes all over his lip.Cold sore began to appear.More appeared on sunday and grew in size.The kit and gel were used up during procedure and were not returned.Reviewed the device/batch history records of chairside kit sku: 881055601540 lot: 19308006 and sku: 22-3764 lot: 19310003.No out of specification or discrepancy was found.Retain sample of zoom 25% gel sku: 22-3764 lot: 19310003, was tested and results were within specifications.Reviewed complaints history, no other similar incident was reported from the same lot numbers.Reviewed direction for use of the kit.The dfu describes steps for candidate qualification, warnings, ingredients, and other precautions.Per complaint information, patient has carried the herpes simplex virus all his life.No additional information regarding the patient condition was available after 3 attempts were made to retrieve information.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.We will continue to monitor the trend.
Event or Problem Description
Discus dental received a complaint on (b)(6) 2020 in which a patient who did the whitening on friday (b)(6) 2020 and after the whitening, he experienced certain effects like chill, shaking and fatigue.The following day, these symptoms were gone.However, started to have herpes all over his lip.The patient sought medical attention and was prescribed medication.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700a south baker ave.; ontario, ca
• MDR Report Key: 9795841
• Report Number: 1000582314-2020-00002
• Device Sequence Number: 11308938
• Product Code: EEG
• UDI-Device Identifier: 00075020034991
• UDI-Public: (01)00075020034991(10)19308006(17)210728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 881055601540
• Device Lot Number: 19308006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/05/2020
• 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: Hospitalization
• Patient Age: 83 YR