ANGIOMAT ILLUMENA 900001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-14 for ANGIOMAT ILLUMENA 900001 manufactured by Liebel-flarsheim.

MAUDE Entry Details

Report Number1518293-2019-00025
MDR Report Key9710895
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-14
Date of Report2019-12-20
Date of Event2019-12-17
Date Mfgr Received2019-12-18
Device Manufacturer Date2008-02-28
Date Added to Maude2020-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameANGIOMAT ILLUMENA
Generic NameANGIOMAT ILLUMENA
Product CodeDXT
Date Received2020-02-14
Model Number900001
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM
Manufacturer Address2111 E GALBRAITH ROAD CINCINNATI, OH US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-14

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