PROGAV 2.0 WITH SA20 A.CONTROL RESERVOIR FX478T

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 2019-11-30 for PROGAV 2.0 WITH SA20 A.CONTROL RESERVOIR FX478T manufactured by Christoph Miethke Gmbh & Co. Kg.

MAUDE Entry Details

Report Number3004721439-2019-00281
MDR Report Key9392484
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2018-07-20
Date Mfgr Received2018-07-27
Device Manufacturer Date2017-08-17
Date Added to Maude2019-11-30
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 ContactMR. JOERG KNEBEL
Manufacturer Street2 ULANENWEG
Manufacturer CityPOTSDAM D, 14469
Manufacturer CountryGM
Manufacturer Postal14469
Manufacturer G1CHRISTOPH MIETHKE GMBH & CO. KG
Manufacturer Street2 ULANENWEG
Manufacturer CityPOTSDAM, 14469
Manufacturer CountryGM
Manufacturer Postal Code14469
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROGAV 2.0 WITH SA20 A.CONTROL RESERVOIR
Generic NameHYDROCEPHALUS VALVES
Product CodeJXG
Date Received2019-11-30
Returned To Mfg2018-07-24
Model NumberFX478T
Catalog NumberFX478T
Lot Number20034662
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCHRISTOPH MIETHKE GMBH & CO. KG
Manufacturer Address2 ULANENWEG POTSDAM, 14469 GM 14469


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-30

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