CUSA CLARITY CONSOLE C7000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for CUSA CLARITY CONSOLE C7000 manufactured by Integra Lifesciences(ireland).

MAUDE Entry Details

Report Number3006697299-2019-00058
MDR Report Key8635904
Date Received2019-05-23
Date of Report2019-05-08
Date of Event2019-05-08
Date Mfgr Received2019-06-10
Device Manufacturer Date2017-02-01
Date Added to Maude2019-05-23
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 ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA LIFESCIENCES(IRELAND)
Manufacturer StreetIDA BUSINESS&TECHNOLOGY PARK
Manufacturer CitySRAGH, TULLAMORE, CO.OFFALY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCUSA CLARITY CONSOLE
Generic NameCUSA CLARITY
Product CodeLBK
Date Received2019-05-23
Catalog NumberC7000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES(IRELAND)
Manufacturer AddressIDA BUSINESS&TECHNOLOGY PARK IDA BUSINESS&TECHNOLOGY PARK SRAGH, TULLAMORE, CO.OFFALY EI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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