BEUDAMED
    FDA Adverse Event Death Summary report: N

    NITI-S PYLORIC & DUODENAL UNCOVERED STENT

    MDR report key: 4484757 · Received January 27, 2015

    Report

    Report Number
    3003902943-2015-00002
    Event Type
    Death
    Date Received
    January 27, 2015
    Date of Event
    July 31, 2012
    Report Date
    August 9, 2012
    Manufacturer
    TAEWOONG MEDICAL CO., LTD
    Product Code
    MUM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER REMARKS: PHYSICIAN'S OPINION: DR. DIDN'T CHECK IT BY ENDOSCOPE AND IT WAS NOT CLEAR THAT THE PERFORATION EXIST OR NOT. IT IS UNLIKELY TO REGARD PERFORATION AS THE CAUSE OF DEATH. PERFORATION FROM PATIENT'S CONDITION IS ONE OF WELL-KNOWN SIDE EFFECT. FOR THIS ISSUE, IT IS DOCUMENTED IN THE PRODUCT'S USER MANUAL. HOWEVER, THE SUSPECTED DEVICE IS NOT REGISTERED TO US FDA AND IT HAS NOT BEEN SHIPPED INTO US.

    Description of Event or Problem · 1

    ON (B)(6) 2012: STENT HAD DEPLOYED. AROUND 4 DAYS AFTER THE PATIENT APPEALED FOR ABDOMINAL PAIN. ON (B)(6) 2012: CT SCAN RESULTED IT SEEMED THERE WAS A PERFORATION -LIKE THING AROUND THE END OF THE STENT. DR. DIDN'T CHECK IT BY ENDOSCOPE AND IT WAS NOT CLEAR THAT THE PERFORATION EXIST OR NOT. THE PATIENT'S CONDITION WAS NOT BAD, DR. DECIDED TO MONITOR THE PATIENT. ON (B)(6) 2012: THE PATIENT DIED. IT IS UNLIKELY TO REGARD PERFORATION AS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60801 NITI-S PYLORIC & DUODENAL UNCOVERED STENT PYLORIC & DUODENAL STENT MUM TAEWOONG MEDICAL CO., LTD DDT2212

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death