NITI-S PYLORIC & DUODENAL UNCOVERED STENT DXDT2210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-14 for NITI-S PYLORIC & DUODENAL UNCOVERED STENT DXDT2210 manufactured by Taewoong Medical Co.,ltd..

MAUDE Entry Details

Report Number3003902943-2019-00022
MDR Report Key8698576
Report SourceDISTRIBUTOR
Date Received2019-06-14
Date of Report2019-05-17
Date of Event2019-04-26
Date Mfgr Received2019-05-17
Device Manufacturer Date2019-01-24
Date Added to Maude2019-06-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LEE
Manufacturer Street14, GOJEONG-RO WOLGOT-MYEON
Manufacturer CityGIMPO-SI, 10022
Manufacturer CountryKS
Manufacturer Postal10022
Manufacturer G1TAEWOONG MEDICAL CO.,LTD.
Manufacturer Street14, GOJEONG-RO WOLGOT-MYEON
Manufacturer CityGIMPO-SI, 10022
Manufacturer CountryKS
Manufacturer Postal Code10022
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNITI-S PYLORIC & DUODENAL UNCOVERED STENT
Generic NamePYLORIC & DUODENAL STENT
Product CodeMUM
Date Received2019-06-14
Model NumberDXDT2210
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTAEWOONG MEDICAL CO.,LTD.
Manufacturer Address14, GOJEONG-RO WOLGOT-MYEON GIMPO-SI, 10022 KS 10022


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization 2019-06-14

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