HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-04-25 for HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140 manufactured by Teleflex Medical.

Event Text Entries

[106620162] (b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the defect was not provided at the time of this report. A device history record review could not be conducted since the lot number was not provided. Customer complaint cannot be confirmed based only on the information provided. A root cause is unknown. To perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish any corresponding corrective actions, it is necessary to evaluate the sample involved in this complaint. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[106620163] Customer complaint alleges the intubated patient has bitten through two bite blocks. (event 2 of 2 captured in mfr. Rpt. # 3004365956-2018-00135). Medical intervention reported was retrieval of bite block with forceps. There was no report of injury or complication due to the alleged device event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2018-00134
MDR Report Key7462429
Report SourceFOREIGN,USER FACILITY
Date Received2018-04-25
Date of Report2018-04-19
Date of Event2018-04-12
Date Mfgr Received2018-04-19
Date Added to Maude2018-04-25
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 ContactLINDA WOODALL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9196942566
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 ORAL BITE BLOCK,INTL
Generic NameENDOSCOPIC BITE BLOCK
Product CodeMNK
Date Received2018-04-25
Catalog Number41140
Lot NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-04-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.