CELSITE 4436962

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 2020-03-12 for CELSITE 4436962 manufactured by B.braun Medical Sas.

MAUDE Entry Details

Report Number9612452-2020-00010
MDR Report Key9822704
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-12
Date of Report2020-03-11
Date of Event2019-12-31
Date Mfgr Received2020-02-13
Device Manufacturer Date2018-12-20
Date Added to Maude2020-03-12
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 ContactMRS CATHERINE BOISMENU
Manufacturer Street30 AVENUE DES TEMPS MODERNES
Manufacturer CityCHASSENEUIL DU POITOU, 86360
Manufacturer CountryFR
Manufacturer Postal86360
Manufacturer G1B.BRAUN MEDICAL SAS FRANCE
Manufacturer Street30 AVENUE DES TEMPS MODERNES
Manufacturer CityCHASSENEUIL DU POITOU, 86360
Manufacturer CountryFR
Manufacturer Postal Code86360
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELSITE
Generic NameACCESS PORT SYSTEM
Product CodeLJT
Date Received2020-03-12
Model Number4436962
Lot Number36941355
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB.BRAUN MEDICAL SAS
Manufacturer Address26 RUE ARMENGAUD SAINT CLOUD, 92210 FR 92210


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-12

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