HUDSON RCI BITE GUARD 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 06,07 report with the FDA on 2011-05-03 for HUDSON RCI BITE GUARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.

Event Text Entries

[20216357] The event is reported as: complaint alleges that external portion of the bite guard separated from the piece that sits internally between the patient's molars which was causing difficulty to remove the bite guard from the patient's mouth. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[20394455] No sample or lot number is available for the manufacturer to investigate. Conclusions: no conclusion can be established based on lack of sample. No corrective action was taken.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2011-00193
MDR Report Key2102864
Report Source06,07
Date Received2011-05-03
Date of Report2011-04-08
Date Mfgr Received2011-04-21
Date Added to Maude2012-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJASMINE BROWN
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX
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 NameHUDSON RCI BITE GUARD MOLAR BITE BLOCK
Generic NameBITE GUARD MOLAR
Product CodeBRW
Date Received2011-05-03
Model NumberNA
Catalog Number1140
Lot NumberUNK
ID NumberNA
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
10 2011-05-03

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