BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH-BLD CURV SCS TIPS CE

    MDR report key: 513236 · Received January 21, 2004

    Report

    Report Number
    1038548-2004-00007
    Event Type
    Malfunction
    Date Received
    January 21, 2004
    Date of Event
    December 22, 2003
    Report Date
    January 21, 2004
    Manufacturer
    SNOWDEN PENCER INC.
    Product Code
    LRW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE PLASTIC COATING COMPLETELY COVERS THE ROD JOINT AND THE SCISSOR TIPS ARE NOT STAYING ON THE ROD. THE TIP HAS FALLEN OFF IN THE PT (FOUR TIMES). THEY ARE RETURNING 16 TIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWITCH-BLD CURV SCS TIPS CE SWITCHBLADES LRW SNOWDEN PENCER INC. E89-5100 778209

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN