GELSOFT 631407

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-06-26 for GELSOFT 631407 manufactured by Vascutek Ltd.

MAUDE Entry Details

Report Number9612515-2019-00009
MDR Report Key8734321
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-06-26
Date of Report2019-06-26
Date of Event2019-05-02
Date Facility Aware2019-05-29
Report Date2019-05-29
Date Reported to Mfgr2019-05-29
Date Mfgr Received2019-05-29
Device Manufacturer Date2015-03-31
Date Added to Maude2019-06-26
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 ContactMR JASON WHITTLE
Manufacturer StreetNEWMAINS AVENUE INCHINNAN BUSINESS PARK
Manufacturer CityRENFREWSHIRE, PA4 9RR
Manufacturer CountryUK
Manufacturer PostalPA4 9RR
Manufacturer G1VASCUTEK LTD
Manufacturer StreetNEWMAINS AVENUE INCHINNAN BUSINESS PARK
Manufacturer CityRENFREWSHIRE, PA4 9RR
Manufacturer CountryUK
Manufacturer Postal CodePA4 9RR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGELSOFT
Generic NameGELSOFT BIFURCATE
Product CodeMAL
Date Received2019-06-26
Catalog Number631407
Lot Number354821 7609
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age4 YR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVASCUTEK LTD
Manufacturer AddressNEWMAINS AVENUE INCHINNAN BUSINESS PARK RENFREWSHIRE, PA4 9RR UK PA4 9RR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-26

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