WECK EFX SHIELD PORT SITE CLOSURE SYSTEM EFX002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-12 for WECK EFX SHIELD PORT SITE CLOSURE SYSTEM EFX002 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3011137372-2019-00246
MDR Report Key8883695
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-08-12
Date of Report2019-07-17
Date of Event2019-07-17
Date Mfgr Received2019-09-16
Date Added to Maude2019-08-12
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 ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWECK EFX SHIELD PORT SITE CLOSURE SYSTEM
Generic NameINSTRUMENT, LIGATURE PASSING A
Product CodeHCF
Date Received2019-08-12
Catalog NumberEFX002
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-12

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