FDA.reportPublic FDA data

MAUDE MDR 9703585

MDR report key
9703585
Report number
8010047-2020-01318
Event key
0
Event type
3
Date of event
2020-02-03
Date received
2020-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR KAZUTAKA MATSUMOTO
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8 JA
Phone
426-426-4264
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EVIS LUCERA ELITE XENON LIGHT SOURCEXENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCTCLV-290Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-120

Event Narratives#

No narrative records found.