ULTRACLEAN 6IN. BLADE EXTENDED INSULATION 139110EXT

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 2020-03-30 for ULTRACLEAN 6IN. BLADE EXTENDED INSULATION 139110EXT manufactured by Consolidated Medical Equipment.

MAUDE Entry Details

Report Number3007305485-2020-00153
MDR Report Key9897075
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-11
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-30
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 ContactMS TRACEY WEISELBENTON
Manufacturer Street11311 CONCEPT BLVD
Manufacturer CityLARGO, FL
Manufacturer CountryUS
Manufacturer Phone3995557
Manufacturer G1CONSOLIDATED MEDICAL EQUIPMENT
Manufacturer StreetALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA
Manufacturer CityCHIHUAHUA, MEXICO 31136
Manufacturer CountryMX
Manufacturer Postal Code31136
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRACLEAN 6IN. BLADE EXTENDED INSULATION
Generic NameELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product CodeGEI
Date Received2020-03-30
Catalog Number139110EXT
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONSOLIDATED MEDICAL EQUIPMENT
Manufacturer AddressALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, MEXICO 31136 MX 31136


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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