MASK KIT,FIXED VENTURI,ADULT 1098

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 2019-07-01 for MASK KIT,FIXED VENTURI,ADULT 1098 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3004365956-2019-00179
MDR Report Key8750367
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-07-01
Date of Report2019-06-11
Date of Event2019-06-03
Date Mfgr Received2019-06-19
Device Manufacturer Date2018-12-03
Date Added to Maude2019-07-01
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 NameMASK KIT,FIXED VENTURI,ADULT
Generic NameMASK, OXYGEN, LOW CONCENTRATIO
Product CodeBYF
Date Received2019-07-01
Catalog Number1098
Lot Number74M1800478
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-01

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