MI-1000 061514

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 2019-05-31 for MI-1000 061514 manufactured by Medical Illumination Intrnation Inc..

MAUDE Entry Details

Report Number2028295-2019-00002
MDR Report Key8659872
Report SourceHEALTH PROFESSIONAL
Date Received2019-05-31
Date of Report2019-05-31
Date of Event2019-05-13
Date Mfgr Received2019-05-13
Date Added to Maude2019-05-31
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. ROBERT HESS
Manufacturer Street547 LIBRARY STREET
Manufacturer CitySAN FERNANDO CA 91340
Manufacturer CountryUS
Manufacturer Postal91340
Manufacturer Phone8188383025
Manufacturer G1MEDICAL ILLUMINATION INTRNATION INC.
Manufacturer Street547 LIBRARY STREET
Manufacturer CitySAN FERNANDO CA 91340
Manufacturer CountryUS
Manufacturer Postal Code91340
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMI-1000
Generic NameMINOR SURGICAL LIGHT
Product CodeFST
Date Received2019-05-31
Returned To Mfg2019-05-20
Model Number061514
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDICAL ILLUMINATION INTRNATION INC.
Manufacturer Address547 LIBRARY STREET SAN FERNANDO CA 91340 US 91340


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-31

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