BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1193259 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05074
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, THE PACKAGE OF THE SEGURA HEMI BASKET HAD BEEN "SLASHED" AND THE DEVICE WAS UNSTERILE. THE DEVICE WAS NOT USED. IT WAS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA HEMISPHERE STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063801120 11286094

    Patients

    Seq Age Sex Outcome Treatment
    1