OPMI LUMERA T N/A 302608-9020-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-21 for OPMI LUMERA T N/A 302608-9020-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).

MAUDE Entry Details

Report Number9615010-2019-00004
MDR Report Key8725076
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-06-21
Date of Report2019-05-24
Date Mfgr Received2019-05-24
Device Manufacturer Date2017-05-30
Date Added to Maude2019-06-21
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. VERNON BROWN
Manufacturer Street5160 HACIENDA DRIVE
Manufacturer CityDUBLIN CA 94568
Manufacturer CountryUS
Manufacturer Postal94568
Manufacturer Phone9255574689
Manufacturer G1CARL ZEISS MEDITEC AG (OBERKOCHEN)
Manufacturer StreetRUDOLF-EBER-STRASSE 11
Manufacturer CityOBERKOCHEN, 73447
Manufacturer CountryGM
Manufacturer Postal Code73447
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameOPMI LUMERA T
Generic NameOPMI LUMERA T
Product CodeHRM
Date Received2019-06-21
Model NumberN/A
Catalog Number302608-9020-000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (OBERKOCHEN)
Manufacturer AddressRUDOLF-EBER-STRASSE 11 OBERKOCHEN, 73447 GM 73447


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-21

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