HUDSON AEROSOL ELONGATED ADULT MASK 1083

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-06-10 for HUDSON AEROSOL ELONGATED ADULT MASK 1083 manufactured by Teleflex Medical.

Event Text Entries

[3540456] The complaint was reported as: the customer alleges that the hudson mask is not fitting into the fisher and paykel rt 202 humidification/blender tubing very easily and it fall out or comes apart during use. No report of pt injury.
Patient Sequence No: 1, Text Type: D, B5


[10817296] A visual inspection of the product involved in the complaint could not be conducted since the product was not returned. In order to perform a proper investigation it is necessary to evaluate the sample involved in the incident. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record (dhr) for the reported lot number (02k1101804) was reviewed and no non conformance reports were originated for the lot in question that can be associated to the complaint reported. The customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident. If the defective sample becomes available this investigation will be updated with the eval results.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2013-00195
MDR Report Key3165399
Report Source01,06,07
Date Received2013-06-10
Date of Report2013-05-17
Date of Event2013-05-16
Date Mfgr Received2013-05-17
Device Manufacturer Date2011-10-01
Date Added to Maude2013-09-04
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 ContactMARGIE BURTON, RA CLINICAL SPECI
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX
Manufacturer StreetAVE. TRANSFORMACION 5954 PARQUE 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 AEROSOL ELONGATED ADULT MASK
Generic NameAEROSOL MASK
Product CodeCBP
Date Received2013-06-10
Catalog Number1083
Lot Number02K1101804
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
10 2013-06-10

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