EVAC 70 XTRA HP COBLATOR II EIC5874-01

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 2019-11-29 for EVAC 70 XTRA HP COBLATOR II EIC5874-01 manufactured by Arthrocare Corp..

MAUDE Entry Details

Report Number3006524618-2019-00578
MDR Report Key9391873
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-10
Date Mfgr Received2019-11-11
Date Added to Maude2019-11-29
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 ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1ARTHROCARE CORP.
Manufacturer Street7000 W. WILLIAM CANNON
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal Code78735
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVAC 70 XTRA HP COBLATOR II
Generic NameELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product CodeGEI
Date Received2019-11-29
Returned To Mfg2019-11-28
Catalog NumberEIC5874-01
Lot Number1137878
Device Expiration Date2019-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHROCARE CORP.
Manufacturer Address7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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