HUDSON MASK,MEDIUM CONC,ELONG,PED 1042

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 2018-10-10 for HUDSON MASK,MEDIUM CONC,ELONG,PED 1042 manufactured by Teleflex Medical.

Event Text Entries

[123269352] (b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report. 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. Root cause is unknown. No corrective actions can be assigned. If the device sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10


[123269353] Customer complaint alleges device "tubing is coming apart at the mask connection". Alleged malfunction reported occurred during use. No patient injury or consequence reported. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2018-00292
MDR Report Key7952627
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-10-10
Date of Report2018-09-26
Date of Event2018-08-15
Date Mfgr Received2018-10-30
Device Manufacturer Date2018-07-03
Date Added to Maude2018-10-10
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
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,PED
Generic NameMASK, OXYGEN
Product CodeBYG
Date Received2018-10-10
Returned To Mfg2018-10-08
Catalog Number1042
Lot Number74G1800724
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 2018-10-10

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