BITE-GARD MOLAR BITE BLOCK 1140

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-11-18 for BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.

Event Text Entries

[22083966] The event was reported as: the green plastic end became dislodged from the white plastic arm. It was retrieved from the pt's pharynx using a magill forceps. This report is the first of two separate incidents reported. No pt injury reported. No further info available.
Patient Sequence No: 1, Text Type: D, B5


[22256071] The device has been sent to the mfr, but investigation report is not available yet. Investigation is ongoing and a follow up report will be sent as soon as is available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2008-00068
MDR Report Key1235741
Report Source08
Date Received2008-11-18
Date of Report2008-10-29
Date Mfgr Received2008-10-29
Date Added to Maude2009-09-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactANGELA BROWN, MANAGER
Manufacturer Street4024 STIRRUP CREEK DR.
Manufacturer CityDURHAM NC 27703
Manufacturer CountryUS
Manufacturer Postal27703
Manufacturer Phone9194334901
Manufacturer G1TELEFLEX MEDICAL-NEUVO LAREDO
Manufacturer StreetAVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameBITE-GARD MOLAR BITE BLOCK
Generic NameBITE GARD
Product CodeJXL
Date Received2008-11-18
Returned To Mfg2008-10-29
Catalog Number1140
Lot Number3007920407
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
10 2008-11-18

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