HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020852010

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 2019-04-12 for HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020852010 manufactured by Intervascular Sas.

Event Text Entries

[145768329] It was reported that the product is available for investigation, it should be returned to intervascular for examination. A review of the complaint device history records is ongoing, results are pending. The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. 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


[145768330] The hospital reported that during preparation for a procedure, upon opening the graft, it appeared to be a brown spot on the graft. The graft was never implanted. A replacement device was used to complete the procedure. No physician associated. No patient involvement. The date of the event is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1640201-2019-00024
MDR Report Key8510183
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-04-12
Date of Report2019-07-26
Date Mfgr Received2019-06-28
Device Manufacturer Date2017-10-11
Date Added to Maude2019-04-12
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 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 GOLD KNITTED MICROVEL DOUBLE VELOUR
Generic NameVASCULAR POLYESTER GRAFT
Product CodeMAL
Date Received2019-04-12
Returned To Mfg2019-06-03
Model NumberM002020852010
Catalog NumberM002020852010
Lot Number17K11
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTERVASCULAR SAS
Manufacturer AddressZ.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-12

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