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 01,04,08 report with the FDA on 2010-06-02 for BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.

Event Text Entries

[1399100] The event was reported as: device broke during use. The green part of the device was left in back of patient's mouth when it broke. Broken part retrieved. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[8620957] The device sample was not returned for evaluation at the time of this report. The results of the investigation are not available at the time of this report. A follow-up report will be sent when investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2010-00071
MDR Report Key1722253
Report Source01,04,08
Date Received2010-06-02
Date of Report2010-05-06
Date of Event2010-04-26
Date Mfgr Received2010-05-06
Date Added to Maude2010-11-18
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 StreetP.O. BOX 12600
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334901
Manufacturer G1TELEFLEX MEDICAL
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 MOLAR BITE BLOCK
Product CodeJXL
Date Received2010-06-02
Model NumberNA
Catalog Number1140
Lot Number02G0900707
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-02

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