VD/CSFF 821730

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-11 for VD/CSFF 821730 manufactured by Codman & Shurtleff Inc..

MAUDE Entry Details

Report Number2023988-2020-00006
MDR Report Key9821011
Report SourceOTHER
Date Received2020-03-11
Date of Report2020-03-11
Date Mfgr Received2020-02-11
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 ContactMS MICHELLE GREANEY
Manufacturer StreetIDA BUSINESS PARK GORT
Manufacturer CityCONNACHT H91PD92
Manufacturer CountryEI
Manufacturer PostalH91PD92
Manufacturer G1NATUS NEUROLOGY INCORPORATED
Manufacturer Street5955 PACIFIC CENTRE BOULEVARD SAN DIEGO
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVD/CSFF
Generic NameCODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM
Product CodeJXG
Date Received2020-03-11
Model Number821730
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCODMAN & SHURTLEFF INC.
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MASSACHUSETTS, US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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