HUDSON ET TUBE HOLDER, STANDARD 81801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-10 for HUDSON ET TUBE HOLDER, STANDARD 81801 manufactured by Teleflex Medical Sdn. Bhd..

Event Text Entries

[178367595] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[178367596] Customer reported the foam on the upper lip of the device fell off and was found in the patient's bed, mouth, or hanging loose. The device was replaced. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2020-00035
MDR Report Key9686841
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-10
Date of Report2020-01-22
Date of Event2020-01-21
Date Mfgr Received2020-03-11
Date Added to Maude2020-02-10
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 SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON ET TUBE HOLDER, STANDARD
Generic NameTRACHEAL TUBE FIXATION DEVICE
Product CodeCBH
Date Received2020-02-10
Catalog Number81801
Lot NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL SDN. BHD.
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-10

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