MAUDE MDR 6549769

MDR report key
6549769
Report number
1000582314-2017-00005
Event key
0
Event type
3
Date of event
2016-11-29
Date received
2017-05-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. SANJAY PATEL
Address
1700 A S BAKER AVE ONTARIO CA 91761 US
Phone
909-909-9095
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHILIPS ZOOMZOOM CHAIRSIDE WHITENING KIT AND GELDISCUS DENTAL, LLCEEG22-3764R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-0501. S

Event Narratives#

N

Patient 1

DISCUS DENTAL RECEIVED A COMPLAINT ON 04/10/2017, IN WHICH PATIENT CLAIMED IN-OFFICE TOOTH WHITENING PROCEDURE CAUSED SENSITIVITY AND A CRACK ON OCCLUSAL SURFACE ON (B)(6) 2016. THE TOOTH WAS EXTRACTED ON (B)(6) 2017. THE PATIENT TOOK AMOXICILLIN AS A MEDICATION. REVIEWED COMPLAINTS HISTORY OF THE PAST 3 YEARS. NO SIMILAR INCIDENT WAS REPORTED. PER CLINICAL EXPERT ASSESSMENT, NO OCCLUSAL SURFACE SHOULD BE AFFECTED DURING THE CHAIRSIDE WHITENING PROCEDURE IF DFU IS FOLLOWED. CHAIRSIDE WHITENING IS ADVISED ON HEALTHY TEETH AND IT IS RARE FOR A HEALTHY TOOTH TO CRACK OR CHIP DUE TO A WHITENING PROCEDURE. ALTHOUGH, UNLESS THERE WAS AN UNDIAGNOSED CRACK OR CHIP UNRELATED TO THE WHITENING, AND THE WHITENING GEL EXACERBATED THE PAIN AND SENSITIVITY WHICH MADE THE PATIENT AND DENTIST NOTICE THE CRACK ON THE TOOTH. NO CORRECTIVE ACTIONS ARE REQUIRED. DFU IS ADEQUATE AND IT DESCRIBES CANDIDATE QUALIFICATION, SAFETY DIRECTIONS, WARNINGS, AND PRECAUTIONS. DFU STATES TO DISQUALIFY ANY PATIENT WHO IS PERIO-INVOLVED, EXHIBITS FAILING RESTORATIONS OR IS OTHERWISE IN AN UNHEALTHY ORAL STATE. IT ALSO DESCRIBES PATIENTS MORE SUSCEPTIBLE TO SENSITIVITY ARE THOSE WITH KNOWN HYPERSENSITIVITY, UNTREATED CARIES, EXPOSED ROOT SURFACES, DEFECTIVE RESTORATIONS, ORAL TISSUE INJURY, AND UNTREATED PERIODONTAL DISEASE. WITH THE AVAILABLE INFORMATION, DISCUS DENTAL IS UNABLE TO CONFIRM THE COMPLAINT AND TO DETERMINE THE CAUSE. THE WHITENING KIT AND GEL WERE USED.

D

Patient 1

DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017, IN WHICH PATIENT CLAIMED IN-OFFICE TOOTH WHITENING PROCEDURE CAUSED TOOTH SENSITIVITY AND A CRACK ON OCCLUSAL SURFACE ON (B)(6) 2016. THE TOOTH WAS EXTRACTED ON (B)(6) 2017. THE PATIENT TOOK AMOXICILLIN AS A MEDICATION.