BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION TUNA OFFICE

    MDR report key: 385356 · Received March 29, 2002

    Report

    Report Number
    2950887-2002-00001
    Event Type
    Other
    Date Received
    March 29, 2002
    Date of Event
    February 27, 2002
    Report Date
    March 29, 2002
    Manufacturer
    VIDAMED, INC.
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD MODERATE BLEEDING AND A FEW CLOTS APPEARED, BUT TUNA PROCEDURE COMPLETED FINE. WHEN RN INSTRUCTED PT. ABOUT BLEEDING, PT DISCLOSED HAVING LAST OF 4 INJECTIONS FOR HEMORRHOIDS IN 2002. 12 HR AFTER TUNA, PT. ADMITTED TO ER FOR BLEEDING. AFTER IRRIGATION, BLEEDING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION TUNA OFFICE ELECTROSURGICAL ACCESSORY KNS VIDAMED, INC. 6800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization