LEVEL ONE THORACIC 24-015-20-71

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for LEVEL ONE THORACIC 24-015-20-71 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.

MAUDE Entry Details

Report Number9610905-2019-00223
MDR Report Key9391980
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-10-30
Date of Event2019-10-30
Date Facility Aware2019-10-30
Report Date2019-10-30
Date Reported to Mfgr2019-10-30
Date Mfgr Received2019-10-30
Date Added to Maude2019-11-29
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 ContactMS. JENNIFER DAMATO
Manufacturer StreetP.O. BOX 16369
Manufacturer CityJACKSONVILLE FL 32245
Manufacturer CountryUS
Manufacturer Postal32245
Manufacturer Phone9046417746
Manufacturer G1KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
Manufacturer StreetKOLBINGER STRASSE 10
Manufacturer CityMUEHLHEIM/DONAU, 78570
Manufacturer CountryGM
Manufacturer Postal Code78570
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL ONE THORACIC
Generic NamePLATE
Product CodeHRS
Date Received2019-11-29
Model Number24-015-20-71
Lot Number33206694
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
Manufacturer AddressKOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-29

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