FMS VUE PUMP 284002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-16 for FMS VUE PUMP 284002 manufactured by Depuy Mitek Llc Us.

MAUDE Entry Details

Report Number1221934-2020-00860
MDR Report Key9836015
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-03-16
Date of Report2020-03-02
Date of Event2020-02-28
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-16
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1JTE WARSAW MFG SITE
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFMS VUE PUMP
Generic NameDISTENSION UNIT, FLUID, ARTHROSCOPIC
Product CodeHRX
Date Received2020-03-16
Returned To Mfg2020-03-10
Model Number284002
Catalog Number284002
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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