UNSPECIFIED TRACHEAL TUBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for UNSPECIFIED TRACHEAL TUBE manufactured by Mitg - Henequen.

Event Text Entries

[185224061] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185224062] According to the reporter, during use, the patient was having skin reaction around the flange. There was redness and inflammation. The customer changed back to previous material.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00228
MDR Report Key9886851
Report SourceUSER FACILITY
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-26
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 ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1MITG - HENEQUEN
Manufacturer StreetAVENIDA HENEQUEN
Manufacturer CityCD. JUAREZ, CHIHUAHUA
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNSPECIFIED TRACHEAL TUBE
Generic NameTUBE, TRACHEAL (W/WO CONNECTOR)
Product CodeBTR
Date Received2020-03-26
Model NumberUNSPECIFIED TRACHEAL TUBE
Catalog NumberUNSPECIFIED TRACHEAL TUBE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMITG - HENEQUEN
Manufacturer AddressAVENIDA HENEQUEN CD. JUAREZ, CHIHUAHUA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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