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	Sensitivity of Teeth (2427)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(4) 2018, in which the dental office claimed patient was having sensitivity issues after the in-office whitening procedure and patient went to the emergency room.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: 18194028, was tested on (b)(4) 2018, and results were within specifications.Also reviewed the device/batch history records of whitening kit, sku: 881055701540, lot: 18201006 and gel, sku: 22-3764, lot: 18194028.No out of specification or discrepancy was found.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, treatment for sensitivity and other precautions.No product failure or out of specifications was found in the product.Potential of sensitivity may be due to a preexisting sensitivity.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.
Event or Problem Description
Discus dental received a complaint on (b)(4) 2018, in which the dental office claimed patient was having sensitivity issues after the in-office whitening procedure and patient went to the emergency room.

• 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: 7980402
• Report Number: 1000582314-2018-00006
• Device Sequence Number: 16538822
• Product Code: EEG
• UDI-Device Identifier: 00075020035004
• UDI-Public: (01)00075020035004(10)18201006(17)190904
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/18/2018

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: 09/04/2019
• Device Model Number: 881055701540
• Device Lot Number: 18201006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/18/2018
• 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: Hospitalization