OASIS MEDICAL DISPOSBALE INSTRUMENTS 4225

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-05 for OASIS MEDICAL DISPOSBALE INSTRUMENTS 4225 manufactured by Oasis Medical.

MAUDE Entry Details

Report Number2083373-2020-00001
MDR Report Key9794608
Report SourceUSER FACILITY
Date Received2020-03-05
Date of Report2020-03-03
Date of Event2019-12-19
Date Mfgr Received2020-01-03
Device Manufacturer Date2019-04-08
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. EDWARD SANTA ANNA
Manufacturer Street514 SOUTH VERMONT AVENUE
Manufacturer CityGLENDORA, CA
Manufacturer CountryUS
Manufacturer Phone3055400
Manufacturer G1OASIS MEDICAL
Manufacturer Street514 SOUTH VERMONT AVENUE
Manufacturer CityGLENDORA, CA
Manufacturer CountryUS
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOASIS MEDICAL DISPOSBALE INSTRUMENTS
Generic NameLASIK IRRIGATOR, 6 SIDE PORTS
Product CodeKYG
Date Received2020-03-05
Model Number4225
Catalog Number4225
Lot NumberD0419F
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOASIS MEDICAL
Manufacturer Address514 S. VERMONT AVENUE GLENDORA, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-05

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