FDA.reportPublic FDA data

MAUDE MDR 6685182

MDR report key
6685182
Report number
1000582314-2017-00006
Event key
0
Event type
3
Date of event
2017-06-07
Date received
2017-07-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
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, LLCEEG22-376417040004R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-0301. O

Event Narratives#

N

Patient 1

(B)(6) DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017, IN WHICH PATIENT EXPERIENCED A PAIN DURING ZOOM IN-OFFICE WHITENING PROCEDURE, AND A POSSIBLE ALLERGIC REACTION IN THE SAME DAY AT HOME AFTER THE PROCEDURE ON (B)(6) 2017. THE PATIENT'S THROAT CLOSED, LOST HIS VOICE AND EXPERIENCED RUNNY NOSE. THE FAMILY DOCTOR PRESCRIBED ANTIBIOTICS. INVESTIGATION: THE RETAIN SAMPLE OF THE WHITENING GEL, SKU: 22-3764, LOT: 17040004, WAS TESTED ON (B)(6) 2017, AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF GEL, SKU: 22-3764, LOT: 17040004, ZOOM WHITENING KIT, SKU: 881055601540, LOT: 17020028, (B)(4), AND ZOOM WHITESPEED LAMP, SKU: ZM3000, SN: (B)(4). NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOT NUMBERS. THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. POTENTIAL CAUSE MAY BE AN ALLERGIC REACTION TO ONE OF THE PRODUCT INGREDIENTS. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. (B)(4). THE WHITENING KIT AND GEL WERE USED.

D

Patient 1

(B)(6) DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017, IN WHICH PATIENT EXPERIENCED A PAIN DURING ZOOM IN-OFFICE WHITENING PROCEDURE, AND A POSSIBLE ALLERGIC REACTION IN THE SAME DAY AT HOME AFTER THE PROCEDURE ON (B)(6) 2017. THE PATIENT'S THROAT CLOSED, LOST HIS VOICE AND EXPERIENCED RUNNY NOSE. THE FAMILY DOCTOR PRESCRIBED ANTIBIOTICS.