LIFESTREAM UNKNOWN LIFESTREAM US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-11-05 for LIFESTREAM UNKNOWN LIFESTREAM US manufactured by Clearstream Technologies Ltd..

MAUDE Entry Details

Report Number9616666-2019-00140
MDR Report Key9282334
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2019-11-05
Date of Report2019-11-05
Date of Event2018-12-21
Date Mfgr Received2019-10-09
Date Added to Maude2019-11-05
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 ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1CLEARSTREAM TECHNOLOGIES LTD.
Manufacturer StreetMOYNE UPPER
Manufacturer CityENNISCORTHY, CO. WEXFORD N A
Manufacturer CountryEI
Manufacturer Postal CodeN A
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIFESTREAM
Generic NameBALLOON EXPANDABLE VASCULAR STENT GRAFT
Product CodePRL
Date Received2019-11-05
Catalog NumberUNKNOWN LIFESTREAM US
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCLEARSTREAM TECHNOLOGIES LTD.
Manufacturer AddressMOYNE UPPER ENNISCORTHY, CO. WEXFORD N A EI N A


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-05

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