M530 OH6

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 2019-10-03 for M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.

MAUDE Entry Details

Report Number3003974370-2019-00010
MDR Report Key9150077
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-03
Date of Report2019-11-28
Date of Event2019-09-09
Date Mfgr Received2019-09-09
Device Manufacturer Date2017-11-08
Date Added to Maude2019-10-03
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. ROLAND JEHLE
Manufacturer StreetMAX-SCHMIDHEINY-STRASSE 201
Manufacturer CityHEERBRUGG, SANKT GALLEN 9435
Manufacturer CountrySZ
Manufacturer Postal9435
Manufacturer G1LEICA INSTRUMENTS (SINGAPORE) PTE LTD
Manufacturer Street12 TEBAN GARDENS CRESCENT
Manufacturer CitySINGAPORE, 608924
Manufacturer CountrySN
Manufacturer Postal Code608924
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameM530 OH6
Generic NameSURGIAL MICROSCOPE
Product CodeEPT
Date Received2019-10-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEICA MICROSYSTEMS (SCHWEIZ) AG
Manufacturer AddressMAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, 9435 SZ 9435


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-03

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