FDA.reportPublic FDA data

MAUDE MDR 2216387

MDR report key
2216387
Report number
2032714-2011-00002
Event key
0
Event type
3
Date of event
2011-06-06
Date received
2011-07-28
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#

Address
8550 HIGUERA ST. CULVER CITY CA 90232 US
Phone
310-310-3108
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZOOM WHITENING LAMP AND PROCEDURE KITDISCUS DENTAL, LLCEEGZM2564ZM256410321018R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-2801. O

Event Narratives#

D

Patient 1

PT SAID THAT HE WAS FEELING ZINGERS (TOOTH SENSITIVITY) DURING THE 3RD OF 4 CYCLES. WANTED TO CONTINUE ON TO 4TH CYCLE. AFTER THE 4TH CYCLE HE CONTINUED TO HAVE SENSITIVITY ISSUES. DR. PRESCRIBED THE PT VICODINE. HYGIENIST REPORTED THE PT DID NOT PARTICIPATE IN THE SENSITIVITY PROTOCOL WHICH SUGGESTS TO BRUSH WITH A FLUORIDE TOOTHPASTE TWO WEEKS IN ADVANCE OF A CHAIR SIDE WHITENING PROCEDURE.

N

Patient 1

REVIEWED THE DHR FOR THE ZOOM WHITENING SYSTEM. THE LAMP USED IN THE PROCEDURE WAS WITHIN THE MFG SPECIFICATIONS UPON SHIPMENT TO THE CUSTOMER. THE RETAIN SAMPLE OF THE CHAIR SIDE GEL USED IN THE PROCEDURE (AND GOES DIRECTLY ON THE TEETH) WAS WITHIN ALL MFG SPECIFICATIONS. THE MFG WORK ORDER FOR THE WAS REVIEWED AS WELL AND NO ABNORMALITIES FOUND IN THE PRODUCTION RUN OF THE GEL LOT NUMBER IN QUESTION. IN ADDITION AN ONLINE REPORT WAS SUBMITTED ON (B)(4) 2011 IN ERROR. THE ONLY PROOF A REPORT WAS SUBMITTED IS ATTACHED. FDA INVESTIGATOR REQUESTED THAT AN ADD'L REPORT BE SUBMITTED IN THIS FORMAT AND CERTIFIED MAIL TO MEDWATCH.