UNKNOWN_ARRINEX_PRODUCT UNK_INS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for UNKNOWN_ARRINEX_PRODUCT UNK_INS manufactured by Arrinex, Inc..

MAUDE Entry Details

Report Number3015132143-2020-00003
MDR Report Key9869536
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-23
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 ContactMR. TRACEY HENRY
Manufacturer Street127 INDEPENDENCE DR.
Manufacturer CityMENLO PARK CA
Manufacturer CountryUS
Manufacturer Phone8883086018
Manufacturer G1ARRINEX, INC.
Manufacturer Street127 INDEPENDENCE DR.
Manufacturer CityMENLO PARK CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN_ARRINEX_PRODUCT
Generic NameCRYOABLATION DEVICE
Product CodeGEH
Date Received2020-03-23
Model NumberUNKNOWN
Catalog NumberUNK_INS
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARRINEX, INC.
Manufacturer Address127 INDEPENDENCE DR. MENLO PARK CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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