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 Codes	Red Eye(s) (2038); Caustic/Chemical Burns (2549)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(4) 2017 in which the dental office manager reported that the gel from take home teeth whitening syringe got into his eye when he was closing the syringe.He rinsed his eye with water, and since the eye was still red after the incident he visited a doctor.He responded later the same day that he is ok.Investigation: the retain sample of the take home whitening gel, sku: (b)(4), lot: 17279015 was tested on 11/21/2017 and results were within specifications.Reviewed device history records of zoom whitening kit, sku: (b)(4), lot: 17299012, and take home whitening gel, sku: (b)(4), lot: 17279015 and no out of specification or discrepancy was found in the records.Reviewed complaints history, no other similar incidents were reported since january 2015.No other similar incident was reported from all finished kits that take home whitening gel, sku: (b)(4), lot: 17279015 was used.Based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device.Potential cause will be user error and applying pressure to the plunger when closing the syringe cap.Zoom take home dfu is adequate and it describes the warnings and precautions when handling the take home syringe (section 4), and first aid instructions if gel gets into eyes (section 5)." warnings: remove cap safely, contents may be under pressure.Risk of serious damage to the eyes.First aid instructions:.If hydrogen peroxide (hp) or carbamide peroxide (cp) gel gets into eyes, on skin or hair, flush with running water." based on the investigation results, no product failure and out of specification was found.Dfu is adequate and no corrective action is needed.
Event or Problem Description
Discus dental received a complaint on (b)(4) 2017 in which the dental office manager reported that the gel from take home teeth whitening syringe got into his eye when he was closing the syringe.He rinsed his eye with water, and since the eye was still red after the incident (no burning), he visited a doctor.He responded later the same day that he is ok.

• 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: 7111519
• Report Number: 1000582314-2017-00010
• Device Sequence Number: 18853398
• Product Code: EEG
• UDI-Device Identifier: 00075020065780
• UDI-Public: (01)00075020065780(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): 12/12/2017

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: Other
• 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: 11/17/2017
• Initial Report FDA Received Date: 12/12/2017
• 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