RX HERCULINK ELITE RENAL STENT SYSTEM 1011504-18

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 2019-06-04 for RX HERCULINK ELITE RENAL STENT SYSTEM 1011504-18 manufactured by Av-temecula-ct.

MAUDE Entry Details

Report Number2024168-2019-04357
MDR Report Key8667115
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-06-04
Date of Report2019-07-25
Date of Event2019-03-22
Date Mfgr Received2019-07-03
Device Manufacturer Date2016-08-01
Date Added to Maude2019-06-04
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 ContactCONNIE SPECK
Manufacturer StreetABBOTT VASCULAR 26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
Manufacturer StreetABBOTT VASCULAR 26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRX HERCULINK ELITE RENAL STENT SYSTEM
Generic NameRENAL STENT SYSTEM
Product CodeNIN
Date Received2019-06-04
Catalog Number1011504-18
Lot Number6080561
Device Expiration Date2019-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAV-TEMECULA-CT
Manufacturer AddressABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-04

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