LEICA 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 2018-07-27 for LEICA M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.

Event Text Entries

[115189729] (b)(4). An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Patient Sequence No: 1, Text Type: N, H10


[115189770] On (b)(6) 2018, leica microsystems ((b)(6)) ag received a complaint from the (b)(6) stating that three (3) patients had skin ulcerations and one (1) patient had thermal burn immediately following surgery. For this report one patient had skin ulceration immediately following surgery. See manufacturer/importer report numbers: 3003974370-2018-00007 / 3003974370-2018-00009 / 3003974370-2018-00010 for information regarding the other three (3) patients reported in the complaint.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003974370-2018-00008
MDR Report Key7725435
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-07-27
Date of Report2018-09-10
Date of Event2018-02-26
Date Facility Aware2018-07-02
Date Mfgr Received2018-07-02
Device Manufacturer Date2017-08-14
Date Added to Maude2018-07-27
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, SINGAPORE 608924
Manufacturer CountrySN
Manufacturer Postal Code608924
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEICA M530 OH6
Generic NameSURGIAL MICROSCOPE
Product CodeEPT
Date Received2018-07-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age11 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEICA MICROSYSTEMS (SCHWEIZ) AG
Manufacturer AddressMAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, SANKT GALLEN 9435 SZ 9435


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-07-27

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