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

Model Number	881055701540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2017 in which patient experienced swollen lips after in-office zoom teeth whitening procedure.Patient visited urgent care after the incident.No additional information was provided.Investigation: - the retain sample of the in-office whitening gel, sku: 22-3764, lot: 17297005 was tested on (b)(6) 2017 and results were within specifications.- reviewed device history records of zoom whitening kit, sku: 881055701540, lot: 17299012, and whitening gel, sku: 22-3764, lot: 17297005 and no out of specification or discrepancy was found in the records.- reviewed complaints history, no other similar incidents were reported with the same lot numbers.- based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device.Potential causes may be improper lips isolation prior to the procedure or improper alignment of the lamp with the lip retractor.Zoom in-office dfu is adequate and it describes the warnings and precautions and steps for proper lip isolation and alignment of the lamp with the retractor.Based on the investigation results, no product failure and out of specification was found.Dfu is adequate and no corrective action is needed.Product was used up during the procedure.
Event or Problem Description
Discus dental received a complaint on (b)(6) 2017 in which patient experienced swollen lips after in-office zoom teeth whitening procedure.Patient visited urgent care after the incident.No additional information was provided.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE WHITENING KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• MDR Report Key: 7113581
• Report Number: 1000582314-2017-00011
• Device Sequence Number: 16517795
• Product Code: EEG
• UDI-Device Identifier: 00075020035004
• UDI-Public: (01)00075020035004(10)17299012(17)190223
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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: Dentist
• Device Expiration Date: 02/23/2019
• Device Model Number: 881055701540
• Device Lot Number: 17299012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/13/2017
• 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