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

Model Number	22-3764, ZM3000 AND 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	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2020 in which a patient had an adverse effect in the form of throat pain during and after the led lamp in-office zoom whitening procedure.No out of specifications was found in the product.No impact on shipped products from the same lot or other lots produced.No containment action is required.No misuse, and no non-compliance.The 25% gel and the chairside kit were within the expiration date.Relief acp medical device was not used or involved during teeth whitening procedure.Dental office reported that the patient is healing.Non-additional information was provided.Patient sought medical attention; treatment is unknown.The gel and kit were used up during procedure and were not returned.Review of complaint history from january 2018 to july 2020, no throat pain was reported in the usa.However, one similar complaint was reported in (b)(6).Retain sample of 25% gel sku: 22-3464 lot: 20122007 was submitted to the lab for testing and the results were within specifications.Reviewed direction for use of the kit.The dfu describes steps for candidate qualification, warnings, ingredients, safety directions including avoid contact with soft tissue and salivary flow and other precautions.Reviewed risk management report, ingestion of gel that leads to burning of internal organs is covered in the risk report (b)(4), hbsra, zoom ws light acc tooth whitening system.Notified pohc/design site to review risk management file and update as needed.Dental office reported that the patient is healing.No further information was provided.Based on the investigation, there was no product failure and we are unable to conclude actual cause.Reviewed device history record for 25% gel sku: 22-3764 lot: 20122007, chairside kit sku: 881055701540 lot: 20071020 with udi number (b)(4) and whitespeed lamp sku: zm3000 serial # (b)(4).No out of specification or discrepancy was found in the records.Based on the investigation results and available information, discus dental concludes there was no failure in retain sample of 25% gel sku: 22-3764 lot: 20122007.No corrective actions are required.
Event or Problem Description
Discus dental received a complaint on (b)(6) 2020 in which a patient had an adverse effect in the form of throat pain during and after the led lamp in-office zoom whitening procedure.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE LAMP
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700a south baker ave.; ontario, ca
• MDR Report Key: 10281374
• Report Number: 1000582314-2020-00003
• Device Sequence Number: 11407268
• Product Code: EEG
• UDI-Device Identifier: 00075020035004
• UDI-Public: (01)00075020035004(10)20071020(17)210512
• 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): 07/15/2020

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: 05/12/2021
• Device Model Number: 22-3764, ZM3000 AND 881055701540
• Device Lot Number: 20122007 & 20071020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: 40 YR