HUT EXT DR FINAL ASSY,ST,FPD 414008

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 2020-03-18 for HUT EXT DR FINAL ASSY,ST,FPD 414008 manufactured by Liebel-flarsheim.

MAUDE Entry Details

Report Number1518293-2020-00005
MDR Report Key9848956
Report SourceUSER FACILITY
Date Received2020-03-18
Date of Report2020-02-19
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2015-08-31
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactFRED RECKELHOFF
Manufacturer Street2111 E GALBRAITH ROAD
Manufacturer CityCINCINNATI, OH
Manufacturer CountryUS
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUT EXT DR FINAL ASSY,ST,FPD
Generic NameHUT EXT DR FINAL ASSY,ST,FPD
Product CodeMQB
Date Received2020-03-18
Model Number414008
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM
Manufacturer Address2111 E GALBRAITH ROAD CINCINNATI, OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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