DURAFELX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-04 for DURAFELX manufactured by Tutogen Medical Gmbh.

MAUDE Entry Details

Report Number3002719998-2019-00021
MDR Report Key9272884
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-11-04
Date of Report2019-11-04
Date of Event2019-09-26
Date Mfgr Received2019-10-02
Date Added to Maude2019-11-04
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 ContactMRS LEILA KELLY
Manufacturer Street11621 RESEARCH CIRCLE
Manufacturer CityALACHUA FL 32615
Manufacturer CountryUS
Manufacturer Postal32615
Manufacturer Phone3864188888
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURAFELX
Generic NameBOVINE PERICARDIUM DURAL GRAFT
Product CodeGXQ
Date Received2019-11-04
Lot NumberNZ18450004
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTUTOGEN MEDICAL GMBH
Manufacturer AddressINDUSTRIESTR 6 NEUNKIRCHEN AM BRAND, 91077 GM 91077


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-04

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