BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMMINGBIRD

    MDR report key: 556058 · Received November 15, 2004

    Report

    Report Number
    2951580-2004-00012
    Event Type
    Other
    Date Received
    November 15, 2004
    Report Date
    November 12, 2004
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN OCTOBER 2004, A CLINICAL INCIDENT INVOLVING AN ARTHROCARE ARTHROWAND WAS REPORTED TO ARTHROCARE CORPORATION. THE REPORTED INCIDENT INVOLVED A TURBINATE REDUCTION PROCEDURE IN WHICH DURING THE PROCEDURE THE SPLENOPALATINE ARTERY WAS PERFORATED. TWELVE DAYS FOLLOWING THE PROCEDURE, THE PT RETURNED FOR POSTOPERATIVE BLEEDING. THE PT RECEIVED A TRANSFUSION OF APPROXIMATELY 3 UNITS. THE PT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMMINGBIRD ELECTROSURGICAL DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other