BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCUGUIDE

    MDR report key: 381015 · Received March 6, 2002

    Report

    Report Number
    2411512-2002-00006
    Event Type
    Other
    Date Received
    March 6, 2002
    Date of Event
    January 11, 2002
    Report Date
    February 27, 2002
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Product Code
    FZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE HOOKWIRE BROKE FREE WHILE INSIDE THE PATIENT, COULD NOT BE PALPATED AND WAS LEFT INSIDE. NO FURTHER SURGERY WAS DONE. THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUGUIDE LESION MARKING SYSTEM FZX MANAN MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other