NITI-S ESOPHAGEAL COVERED STENT EST2010F

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 2020-03-10 for NITI-S ESOPHAGEAL COVERED STENT EST2010F manufactured by Taewoong Medical Co.,ltd..

MAUDE Entry Details

Report Number3003902943-2020-00031
MDR Report Key9809345
Report SourceDISTRIBUTOR
Date Received2020-03-10
Date of Report2020-02-12
Date of Event2020-02-06
Date Mfgr Received2020-02-12
Device Manufacturer Date2019-10-26
Date Added to Maude2020-03-10
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 ContactMR. LEE
Manufacturer Street14, GOJEONG-RO WOLGOT-MYEON
Manufacturer CityGIMPO-SI, GYEONGGI-DO 10022
Manufacturer CountryKS
Manufacturer Postal10022
Manufacturer G1TAEWOONG MEDICAL CO.,LTD.
Manufacturer Street14, GOJEONG-RO WOLGOT-MYEON
Manufacturer CityGIMPO-SI, GYEONGGI-DO 10022
Manufacturer CountryKS
Manufacturer Postal Code10022
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNITI-S ESOPHAGEAL COVERED STENT
Generic NameESOPHAGEAL STENT
Product CodeESW
Date Received2020-03-10
Returned To Mfg2020-03-05
Model NumberEST2010F
Catalog NumberEST2010F
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTAEWOONG MEDICAL CO.,LTD.
Manufacturer Address14, GOJEONG-RO WOLGOT-MYEON GIMPO-SI, GYEONGGI-DO 10022 KS 10022


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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