ILED 7 TRIO 4068310

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-13 for ILED 7 TRIO 4068310 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.

MAUDE Entry Details

Report Number9681407-2020-00008
MDR Report Key9706307
Report SourceUSER FACILITY
Date Received2020-02-13
Date of Report2020-01-14
Date of Event2020-01-14
Date Mfgr Received2020-01-14
Device Manufacturer Date2019-10-22
Date Added to Maude2020-02-13
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. STEFFEN ULBRICH
Manufacturer StreetCARL-ZEISS STRASSE 7-9
Manufacturer CitySAALFELD, 07318
Manufacturer CountryGM
Manufacturer Postal07318
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameILED 7 TRIO
Generic NameSURGICAL LIGHT
Product CodeFSY
Date Received2020-02-13
Model Number4068310
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTRUMPF MEDIZIN SYSTEME GMBH + CO. KG
Manufacturer AddressCARL-ZEISS STRASSE 7-9 SAALFELD, 07318 GM 07318


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-13

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