FDA.reportPublic FDA data

MAUDE MDR 8610380

MDR report key
8610380
Report number
3011649314-2019-00152
Event key
0
Event type
3
Date received
2019-05-14
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. TOAN HOANG
Address
2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMFORT HARD-SOFT BITE SPLINTTHERMOFORMED MOUTHGUARD, COMFORT SPLINTSPRISMATIK DENTALCRAFT, INC.MQCNINININ N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-1401. O

Event Narratives#

N

Patient 1

FOLLOW-UPS WERE MADE TO REQUEST FOR MORE INFORMATION ON THE EVENT; HOWEVER, ONLY SOME INFORMATION HAVE BEEN PROVIDED. THE PATIENT DECIDED NOT TO RETURN THE MOUTHGUARD EVEN THOUGH REQUEST WAS MADE BY THE CLINIC. ONCE THE EVALUATION IS COMPLETED AND NEW INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER USING A COMFORT HARD-SOFT BITE SPLINT. THE PATIENT DEVELOPED LESIONS ON SOFT TISSUE AND MUCOSA.