RX HERCULINK ELITE STENT SYSTEM 1011487-12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-13 for RX HERCULINK ELITE STENT SYSTEM 1011487-12 manufactured by Abbott Vascular.

MAUDE Entry Details

Report Number2024168-2019-11801
MDR Report Key9050652
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-09-13
Date of Report2019-11-19
Date of Event2019-08-27
Date Mfgr Received2019-11-07
Device Manufacturer Date2017-08-14
Date Added to Maude2019-09-13
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 ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRX HERCULINK ELITE STENT SYSTEM
Generic NameSTENT, RENAL
Product CodeNIN
Date Received2019-09-13
Returned To Mfg2019-10-14
Catalog Number1011487-12
Lot Number7081461
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-13

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