HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041

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 2018-10-24 for HUDSON MASK,MEDIUM CONC,ELONG,ADULT 1041 manufactured by Teleflex Medical.

Event Text Entries

[124971971] (b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. However material from the production line was verified and no issues were found that can lead this customer complaint. The device history record of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. To perform a proper investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved. Customer complaint cannot be confirmed based only on the information provided. Root cause is unknown. No corrective actions can be assigned. If the device becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[124971972] Customer complaint alleges "the tubing comes off from the mask very easily. " alleged issue reported occurred during use. It was reported there were no consequences for the patient. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2018-00321
MDR Report Key8001439
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-10-24
Date of Report2018-10-16
Date of Event2018-10-01
Date Mfgr Received2018-10-16
Device Manufacturer Date2018-05-11
Date Added to Maude2018-10-24
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 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 MASK,MEDIUM CONC,ELONG,ADULT
Generic NameMASK, OXYGEN
Product CodeBYG
Date Received2018-10-24
Catalog Number1041
Lot Number74E1801729
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-24

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