LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM0801058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-27 for LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM0801058 manufactured by Clearstream Technologies Ltd..

MAUDE Entry Details

Report Number9616666-2019-00071
MDR Report Key8741079
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-27
Date of Report2019-07-18
Date of Event2019-05-22
Date Mfgr Received2019-07-16
Date Added to Maude2019-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJUDITH LUDWIG
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1CLEARSTREAM TECHNOLOGIES LTD.
Manufacturer StreetMOYNE UPPER
Manufacturer CityENNISCORTHY, CO. WEXFORD
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
Generic NameBALLOON EXPANDABLE VASCULAR COVERED STENT
Product CodePRL
Date Received2019-06-27
Returned To Mfg2019-06-27
Catalog NumberLSM0801058
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCLEARSTREAM TECHNOLOGIES LTD.
Manufacturer AddressMOYNE UPPER ENNISCORTHY, CO. WEXFORD EI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-27

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