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

Model Number	881055601540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on 05/24/2018, in which dental assistant reported that in office teeth whitening gel dripped onto patient's mandible.Patient experienced swollen white/grey cervical margins.Dentist recommended magic mouthwash, peroxyl and canker sore otc drug.Patient is doing better, patient continues to use vitamin e oil and magic mouthwash.Reviewed direction for use of the in-office whitening zoom chairside kit.It describes the steps for proper isolation of soft tissue to prevent burn and irritation.It also includes candidate qualification, safety directions, warnings, and precautions.Reviewed device history records for whitening gel part number 22-3764, lot number 18060002, and zoom whitening kit part number 881055601540, lot number 18060004, and no out of specification or discrepancy was found.Tested the retain sample of the whitening gel 22-3764, lot 18060002, and no product failure was detected.Reviewed customer complaints history for 2018, no similar complaints from the same lots.With the available information, discus dental concludes there was no malfunction or failure in the product.No corrective actions are required.The potential cause of this incident can be failure to follow the instructions provided with the product.The whitening kit and gel were used.
Event or Problem Description
Discus dental received a complaint on 05/24/2018, in which dental assistant reported that in office teeth whitening gel dripped onto patient's mandible.Patient experienced swollen white/grey cervical margins.Dentist recommended magic mouthwash, peroxyl and canker sore otc drug.Patient is doing better, patient continues to use vitamin e oil and magic mouthwash.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE WHITENING KIT AND GEL
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700 a south baker ave; ontario CA 91761
• MDR Report Key: 7623659
• Report Number: 1000582314-2018-00004
• Device Sequence Number: 16594137
• Product Code: EEG
• UDI-Device Identifier: 00075020034991
• UDI-Public: (01)00075020034991(10)18060004(17)191211
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: Dental Assistant
• Device Expiration Date: 12/11/2019
• Device Model Number: 881055601540
• Device Catalogue Number: 881055601540
• Device Lot Number: 18060004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/20/2018
• 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: Other