MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for manufactured by .

MAUDE Entry Details

Report NumberCOR18001629-000
MDR Report Key7953907
Date Received2018-10-10
Date of Report2018-10-10
Date Added to Maude2018-10-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMr Alan Vaisman
Manufacturer Street6 Hakidma Street PO Box 240
Manufacturer CityYo 20692
Manufacturer CountryIS
Manufacturer Postal20692
Manufacturer Phone49599044
Manufacturer G1Lumenis Ltd.
Manufacturer Street6 Hakidma Street PO Box 240
Manufacturer CityYokneam 20692
Manufacturer CountryIS
Manufacturer Postal Code20692
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeEWG
Date Received2018-10-10
Device AvailabilityI
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-10

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