FDA.reportPublic FDA data

MAUDE MDR 9552967

MDR report key
9552967
Report number
3011649314-2019-00802
Event key
0
Event type
3
Date received
2020-01-06
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. HERBERT SCHOENHOEFER
Address
2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US
Phone
949-949-9494
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DREAM TAPDREAM TAPPRISMATIK DENTALCRAFT, INC.LRKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0601. R

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT YET BEEN RETURNED. AN INVESTIGATION WILL BE CONDUCTED ONCE THE SAMPLE HAS BEEN RETURNED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WEIGHT: ASKED, BUT UNKNOWN. DATE OF EVENT: ASKED, BUT UNKNOWN. MODEL NUMBER NOT APPLICABLE. CATALOG NUMBER NOT APPLICABLE. LOT NUMBER NOT APPLICABLE. EXPIRATION DATE NOT APPLICABLE. UDI NUMBER NOT AVAILABLE. DEVICE MANUFACTURE DATE NOT AVAILABLE.

D

Patient 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION (DATE UNKNOWN) AFTER WEARING A DREAM TAP NIGHTGUARD. THE PATIENT HAD RED PATCHES ON THE CHEEKS. THE PATIENT HAS NO KNOWN ALLERGIES.