BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRELLIS 8 120X30

    MDR report key: 1694438 · Received May 10, 2010

    Report

    Report Number
    2953724-2010-00074
    Event Type
    Other
    Date Received
    May 10, 2010
    Date of Event
    November 26, 2008
    Report Date
    November 26, 2008
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. IN MARCH 2009, COVIDIEN ACQUIRED BACCHUS MEDICAL. COVIDIEN HAS UNDERTAKEN A REVIEW OF BACCHUS' OLD COMPLAINTS AND DETERMINED THAT CERTAIN COMPLAINTS WERE MDR REPORTABLE. AS A RESULT, COVIDIEN IS FILING THIS MDR REPORT. DUE TO THE NATURE OF THE RECORD KEEPING AND INVESTIGATION PRACTICES OF THE PREVIOUS OWNER, WE ARE UNABLE TO PROVIDED DETERMINATIONS OR CONCLUSIONS ABOUT THE POSSIBLE ROOT CAUSE(S) OF THE ISSUE BEING REPORTED. WE DO NOT EXPECT TO RECEIVE ADDITIONAL INFORMATION ABOUT THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2008 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER REPORTS THAT THE BALLOON HAD TO BE PUNCTURED FROM OUTSIDE THE BODY THROUGH THE PATIENT'S SKIN WITH LARGE BORE NEEDLE TO DEFLATE AND REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT812030 P0830083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention