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

Model Number	22-3764, ZM3000 AND 881055701540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on 11/17/2020 in which a patient had white blister on both upper and lower lip after zoom treatment.Note: patient has allergies on penicillin and latex.This incident did not cause a death, or a serious injury.However, since the patient sought medical attention and was prescribed antibiotics, this incident is being reported to fda.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 was identified based on complaint description.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 slowly.Patient is diabetic and was supposed to eat to at 1pm and procedure finished at 3pm.Therefore, she was lightheaded and sweating from low blood sugar.Patient had a granola bar at the office and felt better after the fact.However, the burn didn't heal as fast and patient was still in pain days after.Patient sought medical attention and was prescribed pain reliever and antibiotic.The gel and kit were used up during procedure and were not returned.Retain sample of 25% gel sku: 22-3764 lot: 20006011 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 for zoom ws light acc tooth whitening system.Thermal burns to to lips/gums remains within acceptable level.Dental office reported that the patient is healing slowly.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: 20006011 expiration date: 05/24/2021, chairside kit sku: 881055701540 lot: 19361006 expiration date: 02/15/2021 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: 20006011.No corrective actions are required.
Event or Problem Description
Discus dental received a complaint on (b)(6) 2020 in which patient had a white blister on both upper and lower lip after zoom treatment.Note: patient has allergies on penicillin and latex.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE LAMP AND CHAIRSIDE KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700a south baker ave.; ontario, ca
• MDR Report Key: 10980023
• Report Number: 1000582314-2020-00005
• Device Sequence Number: 14517711
• Product Code: EEG
• UDI-Device Identifier: 00075020035004
• UDI-Public: (01)00075020035004(10)19361006(17)210215
• 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): 12/09/2020

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: 05/24/2021
• Device Model Number: 22-3764, ZM3000 AND 881055701540
• Device Lot Number: 20006011 & 19361006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/09/2020
• 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: 50 YR