11.5FX20CM SIL.DBLMN HEMO-C SE SL20E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-11 for 11.5FX20CM SIL.DBLMN HEMO-C SE SL20E manufactured by Medical Components, Inc..

MAUDE Entry Details

Report Number2518902-2020-00014
MDR Report Key9818286
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-11
Date of Report2020-03-24
Date of Event2020-01-28
Date Mfgr Received2020-02-12
Device Manufacturer Date2019-02-28
Date Added to Maude2020-03-11
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 ContactLYNN WINKLER
Manufacturer Street1499 DELP DRIVE
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal19438
Manufacturer Phone2152564201
Manufacturer G1MEDICAL COMPONENTS, INC.
Manufacturer Street1499 DELP DRIVE
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal Code19438
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name11.5FX20CM SIL.DBLMN HEMO-C SE
Generic NameHEMO-CATH ST
Product CodeMSD
Date Received2020-03-11
Model NumberSL20E
Catalog NumberSL20E
Lot NumberMNGX260
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDICAL COMPONENTS, INC.
Manufacturer Address1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-11

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