GALAXY G3 MINI 1.5MM X 4CM GLM915040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-17 for GALAXY G3 MINI 1.5MM X 4CM GLM915040 manufactured by Medos International Sarl.

MAUDE Entry Details

Report Number3008114965-2020-00066
MDR Report Key9841955
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-17
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2018-09-25
Date Added to Maude2020-03-17
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 ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1CODMAN & SHURTLEFF, INC. (FREMONT)
Manufacturer Street47709 FREMONT BLVD
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal Code94538
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGALAXY G3 MINI 1.5MM X 4CM
Generic NameNEUROVASCULAR EMBOLIZATION DEVICE
Product CodeKRD
Date Received2020-03-17
Model NumberGLM915040
Catalog NumberGLM915040
Lot NumberL13804
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SARL
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE NEUCHATEL CH-2400 SZ CH-2400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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