HUDSON 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 other,user facility report with the FDA on 2020-02-25 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3004365956-2020-00052
MDR Report Key9751564
Report SourceOTHER,USER FACILITY
Date Received2020-02-25
Date of Report2020-02-06
Date of Event2020-01-09
Date Mfgr Received2020-03-03
Date Added to Maude2020-02-25
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 FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON BITE-GARD MOLAR BITE BLOCK
Generic NameENDOSCOPIC BITE BLOCK
Product CodeMNK
Date Received2020-02-25
Catalog Number1140
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25

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