HUDSON MASK,HIGH CONC,ELONG,ADULT 1007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-21 for HUDSON MASK,HIGH CONC,ELONG,ADULT 1007 manufactured by Teleflex Medical.

Event Text Entries

[133865723] (b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. A device history record review could not be conducted since no lot number was reported. Customer complaint cannot be confirmed based only on the information provided. To perform a proper and thorough investigation and determine the source of defect reported, it is necessary to evaluate the sample involved. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[133865724] Customer complaint alleges the device reservoir bag was not inflated during use on a patient. A new device was obtained for use. No patient harm was reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2019-00011
MDR Report Key8264289
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-01-21
Date of Report2019-01-07
Date of Event2019-01-07
Date Mfgr Received2019-02-28
Date Added to Maude2019-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 MASK,HIGH CONC,ELONG,ADULT
Generic NameMASK, OXYGEN
Product CodeBYG
Date Received2019-01-21
Returned To Mfg2019-02-07
Catalog Number1007
Lot NumberUNKNOWN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-21

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