BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON-LEUNG BILIARY STENT SET

    MDR report key: 7573635 · Received June 6, 2018

    Report

    Report Number
    3001845648-2018-00265
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 8, 2018
    Report Date
    June 5, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS COMPLAINT IS BEING SUBMITTED AS A CANCELLATION REPORT AS IT HAS BEEN CONFIRMED THAT THE STENT INVOLVED WAS NOT MANUFACTURED BY COOK.

    Description of Event or Problem · 0

    THE PATIENT USED COOK'S AND BOSTON'S STENT AT THE SAME TIME FOR 2 MONTHS, FINALLY THEY FOUND THAT COOK'S STENT WAS BLOCKED BUT BOSTON'S DIDN'T.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT AS IT WAS CONFIRMED THAT THE DEVICE INVOLVED WAS MADE BY COOK. THE PATIENT USED COOK'S AND BOSTON'S STENT AT THE SAME TIME FOR 2 MONTHS, FINALLY THEY FOUND THAT COOK'S STENT WAS BLOCKED BUT BOSTON'S DIDN'T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415849 COTTON-LEUNG BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD FGE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention