LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSMU1350958

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-08 for LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSMU1350958 manufactured by Clearstream Technologies Ltd..

MAUDE Entry Details

Report Number9616666-2019-00104
MDR Report Key9169088
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-08
Date of Report2019-11-19
Date of Event2019-09-11
Date Mfgr Received2019-11-12
Device Manufacturer Date2019-03-21
Date Added to Maude2019-10-08
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 BALLOON EXPANDABLE VASCULAR COVERED STENT
Generic NameBALLOON EXPANDABLE VASCULAR COVERED STENT
Product CodePRL
Date Received2019-10-08
Returned To Mfg2019-11-04
Model NumberLSMU1350958
Catalog NumberLSMU1350958
Lot NumberCMDQ0442
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 N A EI N A


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-08

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