FDA.reportPublic FDA data

MAUDE MDR 9444856

MDR report key
9444856
Report number
3011649314-2019-00763
Event key
0
Event type
3
Date received
2019-12-10
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.LRKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-1001. 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. PATIENT WEIGHT: ASKED, BUT UNKNOWN. DATE OF EVENT: ASKED, BUT UNKNOWN. MODEL NUMBER: NOT APPLICABLE. CATALOG NUMBER: NOT APPLICABLE. LOT NUMBER: NOT APPLICABLE. UDI: NOT AVAILABLE. INITIAL REPORTER: NOT AVAILABLE.

D

Patient 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER USING A DREAM TAP APPLIANCE. ACCORDING TO THE INFORMATION PROVIDED BY THE DOCTOR, THE PATIENT EXPERIENCED REDNESS AND SWELLING OF HER LIPS AND GUM TISSUE, WHERE THEY CAME IN CONTACT WITH THE DEVICE. THE PATIENT DIDN'T NOTICE THE REACTION RIGHT AWAY AND IS NOT SURE IF APPLIANCE IS WHAT IS CAUSING THE REACTION. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAS ANY KNOWN ALLERGIES. THE PATIENT HAS THE SAMPLE WITH HER AND IT IS UNKNOWN IF SUCH A SAMPLE IS BEING RETURNED.