BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDE WIRE STAINLESS STEEL

    MDR report key: 385040 · Received March 25, 2002

    Report

    Report Number
    3025141-2001-00002
    Event Type
    Other
    Date Received
    March 25, 2002
    Date of Event
    April 13, 2001
    Report Date
    March 23, 2002
    Manufacturer
    ACUMED, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE GUIDE WIRE BROKE. A FRAGMENT OF THE WIRE WAS LEFT IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE STAINLESS STEEL GUIDE WIRE DQX ACUMED, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other