VISUAL-ICE? CRYOABLATION SYSTEM FPRCH6000

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 2020-03-26 for VISUAL-ICE? CRYOABLATION SYSTEM FPRCH6000 manufactured by Galil Medical Ltd.

MAUDE Entry Details

Report Number3004462490-2020-00002
MDR Report Key9886251
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-02-21
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-26
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. SANDRA BAUSBACK-ABALLO
Manufacturer Street300 CONSHOHOCKEN STATE RD 300 FOUR FALLS CORPORATE CTR
Manufacturer CityWEST CONSHOHOCKEN, PA
Manufacturer CountryUS
Manufacturer Phone3311537
Manufacturer G1GALIL MEDICAL LTD.
Manufacturer Street4364 ROUND LAKE ROAD W
Manufacturer CityARDEN HILLS, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVISUAL-ICE? CRYOABLATION SYSTEM
Generic NameCRYOSURGICAL DEVICES AND ACCESSORIES
Product CodeGEH
Date Received2020-03-26
Model NumberFPRCH6000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGALIL MEDICAL LTD
Manufacturer Address1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM 2069203 IS 2069203


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.