REUSABLE ELECTRODE, 10CM, NITINOL NE-RF-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for REUSABLE ELECTRODE, 10CM, NITINOL NE-RF-10 manufactured by Neurotherm, Inc.

MAUDE Entry Details

Report Number3004617090-2020-00001
MDR Report Key9703336
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-12
Date of Report2020-02-12
Date of Event2020-01-28
Date Mfgr Received2020-01-29
Date Added to Maude2020-02-12
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1NEUROTHERM, INC
Manufacturer Street600 RESEARCH DRIVE STE 1
Manufacturer CityWILMINGTON MA 01887
Manufacturer CountryUS
Manufacturer Postal Code01887
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREUSABLE ELECTRODE, 10CM, NITINOL
Generic NamePROBE, RADIOFREQUENCY LESION
Product CodeGXD
Date Received2020-02-12
Returned To Mfg2020-02-06
Model NumberNE-RF-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNEUROTHERM, INC
Manufacturer Address600 RESEARCH DRIVE STE 1 WILMINGTON MA 01887 US 01887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-12

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