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

Model Number	881055701540
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	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2020 in which a patient experienced allergy "breathing difficulties", "red blushes/big hives on neck and throat" with the 25 %hp gel 1st & 2nd in office zoom.The dentist attempted to undergo zoom whitening treatment, the first attempt was stopped when seeing the allergic reaction in the form of breathing difficulties of the patient.A second attempt of zoom treatment was stopped again as the allergic reaction of "red blushes and big hives on the neck and throat".The kit and gel were used up during procedure and were not returned.Reviewed the device/batch history records of chairside kit sku: 881055701540, 25% gel lot: 19063027 sku: 22-3764 lot: 19059023 and zoom whitespeed lamp sku: zm3000 serial number: (b)(4).No out of specification or discrepancy was found.Retain sample of zoom 25% gel sku: 22-3764 lot: 19059023, 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.Potential cause may be an allergic reaction to one of the product ingredients.No hospitalization or prescription drug required to treat allergy.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 experienced allergy "breathing difficulties", "red blushes/big hives on neck and throat" with the 25 %hp gel 1st & 2nd in office zoom.The dentist attempted to undergo zoom whitening treatment, the first attempt was stopped when seeing the allergic reaction in the form of breathing difficulties of the patient.A second attempt of zoom treatment was stopped again as the allergic reaction of "red blushes and big hives on the neck and throat".

• 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: 9766220
• Report Number: 1000582314-2020-00001
• Device Sequence Number: 2788226
• Product Code: EEG
• UDI-Device Identifier: 00075020035004
• UDI-Public: (01)00075020035004(10)19063027(17)200606
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/21/2020

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: 06/06/2020
• Device Model Number: 881055701540
• Device Lot Number: 19063027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/27/2020
• 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: Other