BITEGARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-31 for BITEGARD manufactured by Teleflex Medical - Hudson Rci -.

Event Text Entries

[16582787] Bitegard separated in pt's mouth requiring removal with forceps.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022925
MDR Report Key2324763
Date Received2011-10-31
Date of Report2011-10-31
Date of Event2011-10-09
Date Added to Maude2011-11-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBITEGARD
Generic NameORAL BITE BLOCK
Product CodeJXL
Date Received2011-10-31
Returned To Mfg2011-10-18
ID NumberREF 1140
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL - HUDSON RCI -
Manufacturer AddressRESEARCH TRIANGLE PARK NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-10-31

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