FDA.reportPublic FDA data

MAUDE MDR 1765597

MDR report key
1765597
Report number
3004365956-2010-00129
Event key
0
Event type
3
Date of event
2010-06-09
Date received
2010-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ANGELA BROWN, MGR
Address
PO BOX 12600 RTP NC 27709 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HUDSON BITE-GARD MOLAR BITE BLOCKBITE BLOCKTELEFLEX MEDICALJXLNA1140UNKR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-07-060

Event Narratives#

D

Patient 1

THE EVENT IS REPORTED AS: THE BITE-GARD WAS BITTEN INTO BY THE PATIENT. NO PT INJURY REPORTED.

N

Patient 1

THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.