EDI CATHETER ENFIT 8FR/50 CM 6883900

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 2020-01-29 for EDI CATHETER ENFIT 8FR/50 CM 6883900 manufactured by Maquet Critical Care Ab.

MAUDE Entry Details

Report Number8010042-2020-00052
MDR Report Key9641957
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-29
Date of Report2020-03-25
Date of Event2020-01-10
Date Mfgr Received2020-01-14
Date Added to Maude2020-01-29
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 StreetMAQUET CRITICAL CARE AB R
Manufacturer CitySOLNA
Manufacturer CountrySW
Manufacturer G1MAGNUS LINDQVIST
Manufacturer StreetMAQUET CRITICAL CARE AB R
Manufacturer CitySOLNA
Manufacturer CountrySW
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEDI CATHETER ENFIT
Generic NameGASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Product CodePIF
Date Received2020-01-29
Model Number8FR/50 CM
Catalog Number6883900
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CRITICAL CARE AB
Manufacturer AddressROENTGENVAGEN 2 SOLNA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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