VASCULAR POLYESTER GRAFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-04 for VASCULAR POLYESTER GRAFT manufactured by Intervascular Sas.

Event Text Entries

[132053134] (b)(4). No investigation could be performed to date since there is no event description or graft identification available. Additional information is being sought. The investigation is still ongoing. A follow up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[132053135] The patient's vascular graft (type unknown) had become infected and the surgeon wondered if this infection was due to a product change. Getinge was aware of this from an off-hand conversation with the hospital materials coordinator. No additional information could be retrieved to date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1640201-2019-00001
MDR Report Key8216856
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-01-04
Date of Report2019-03-14
Date Facility Aware2018-12-06
Date Mfgr Received2018-12-06
Date Added to Maude2019-01-04
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 ContactMRS. LAURE FRAYSSE
Manufacturer StreetZ.I. ATHELIA I
Manufacturer CityLA CIOTAT CEDEX, 13705
Manufacturer CountryFR
Manufacturer Postal13705
Manufacturer G1MAQUET CARDIOVASCULAR LLC (IMPORTER)
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal Code07470
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameVASCULAR POLYESTER GRAFT
Product CodeMAL
Date Received2019-01-04
Device Availability*
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. Other 2019-01-04

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