4580 FMS DUO+ PUMP/SHAVER COMBO -NS 284580

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for 4580 FMS DUO+ PUMP/SHAVER COMBO -NS 284580 manufactured by Depuy Mitek Llc Us.

MAUDE Entry Details

Report Number1221934-2020-00915
MDR Report Key9856072
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-19
Date of Report2020-03-05
Date of Event2020-02-28
Date Mfgr Received2020-04-02
Date Added to Maude2020-03-19
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 G1DEPUY MITEK
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Generic NameDISTENSION UNIT, FLUID, ARTHROSCOPIC
Product CodeHRX
Date Received2020-03-19
Returned To Mfg2020-03-19
Model Number284580
Catalog Number284580
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 2020-03-19

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