BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 2636014 · Received June 29, 2012

    Report

    Report Number
    3005099803-2012-02336
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN ESCAPE RETRIEVAL BASKET. ACCORDING TO THE COMPLAINANT, DURING UNPACKING OF THE DEVICE IT WAS NOTED THAT THE PLASTIC POUCH WAS CUT AND THE STERILITY WAS COMPROMISED. NO DAMAGE TO THE OUTER SHIPPING BOX WAS NOTED. NO PROCEDURE OR PATIENT WAS INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 15142417

    Patients

    Seq Age Sex Outcome Treatment
    1