BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA CATHETER

    MDR report key: 833814 · Received April 2, 2007

    Report

    Report Number
    6000037-2007-00015
    Event Type
    Injury
    Date Received
    April 2, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    PMA / PMN Number
    k944290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FEBRUARY 2007 15-MONTH TREND REPORT FOR ALL COMPLAINT FAILURE MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTRED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 8975103 AND REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. IN 2007 THAT A PATIENT UNDERWENT THE REMOVAL OF A FLEXIMA 8F DRAINAGE CATHETER. THE PHYSICIAN STATED THAT DUE TO DIFFICULTY REMOVING THE CATHETER, GENERAL ANESTHESIA WAS REQUIRED. THE COMPLAINANT HAS REPORTED THAT NO SERIOUS INJURY HAS OCCURRED. REPEATED ATTEMPTS TO OBTAIN ADDITIONAL DETAILS ON THIS EVENT HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER DRAINAGE CATHETER FGE BOSTON SCIENTIFIC CORP. 27-134 8975103

    Patients

    Seq Age Sex Outcome Treatment
    1 YR