BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRETTA SYSTEM

    MDR report key: 466188 · Received June 16, 2003

    Report

    Report Number
    2954281-2003-00003
    Event Type
    Other
    Date Received
    June 16, 2003
    Date of Event
    May 1, 2003
    Report Date
    June 16, 2003
    Manufacturer
    CURON MEDICAL, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THROUGH A SALES REP, THE MANUFACTURER WAS INFORMED ON MAY 15, 2003, THAT A PT WAS HOSPITALIZED AFTER A PROCEDURE USING THE PRODUCT. VERY LIMITED INFO ABOUT THE EVENT HAS BEEN RECEIVED FROM THE PHYSICIAN DESPITE SEVERAL ATTEMPTS TO OBTAIN SUCH INFO. ADDITIONAL INFO WILL BE PROVIDED TO THE FDA AS SOON AS IT IS AVAILABLE. BECAUSE OF THE LIMITED INFO CURRENTLY AVAILABLE, ANY CAUSAL CONNECTION BETWEEN THE DEVICE AND THE EVENT IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRETTA SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES. JOS CURON MEDICAL, INC. 4301K NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization NA (NA TO NA).