MICRO TORNADO HP W HANDCONTROL 283512

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 2020-03-17 for MICRO TORNADO HP W HANDCONTROL 283512 manufactured by Depuy Mitek Llc Us.

MAUDE Entry Details

Report Number1221934-2020-00871
MDR Report Key9842057
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-17
Date of Report2020-03-15
Date of Event2020-01-01
Date Mfgr Received2020-03-15
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1MITEK RAYNHAM MFG
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 NameMICRO TORNADO HP W HANDCONTROL
Generic NameLINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
Product CodeHRX
Date Received2020-03-17
Returned To Mfg2020-01-30
Model Number283512
Catalog Number283512
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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