FDA.reportPublic FDA data

MAUDE MDR 2324763

MDR report key
2324763
Report number
MW5022925
Event key
0
Event type
3
Date of event
2011-10-09
Date received
2011-10-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BITEGARDORAL BITE BLOCKTELEFLEX MEDICAL - HUDSON RCI -JXL R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-3101. O

Event Narratives#

D

Patient 1

BITEGARD SEPARATED IN PT'S MOUTH REQUIRING REMOVAL WITH FORCEPS.