HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175926P0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-02 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175926P0 manufactured by Intervascular Sas.

Event Text Entries

[122328675]
Patient Sequence No: 1, Text Type: N, H10


[122328676] During surgery for aneurysmal disease, the graft had a serious hole bleeding problem. There was no transfusion during the surgery. Surgeon used drugs as bioglue to stop bleeding. The patient remained implanted and stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1640201-2018-00020
MDR Report Key7925828
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-10-02
Date of Report2018-11-20
Date of Event2018-07-24
Date Mfgr Received2018-11-19
Device Manufacturer Date2018-05-23
Date Added to Maude2018-10-02
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. LAURE FRAYSSE
Manufacturer StreetZ.I. ATHELIA I
Manufacturer CityLA CIOTAT CEDEX, 13705
Manufacturer CountryFR
Manufacturer Postal13705
Manufacturer G1INTERVASCULAR SAS
Manufacturer StreetZ.I. ATHELIA I
Manufacturer CityLA CIOTAT CEDEX, 13705
Manufacturer CountryFR
Manufacturer Postal Code13705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
Generic NameVASCULAR POLYESTER GRAFT
Product CodeMAL
Date Received2018-10-02
Model NumberM00202175926P0
Catalog NumberM00202175926P0
Lot Number18E23
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERVASCULAR SAS
Manufacturer AddressZ.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-02

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