BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 300045 · Received October 12, 2000

    Report

    Report Number
    2954281-2000-00002
    Event Type
    Injury
    Date Received
    October 12, 2000
    Date of Event
    July 21, 2000
    Report Date
    October 9, 2000
    Manufacturer
    CURON MEDICAL, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CURON MEDICAL INC., WAS NOTIFIED ON 07/24/2000 THAT ON 7/12/2000 THE PT COMPLAINED ABOUT LEFT SIDE CHEST PAIN; PT WAS KEPT IN THE HOSP OVERNIGHT FOR OBSERVATION AND WAS RELEASED ON 07/13/2000 COMPLETELY RECOVERED. HOWEVER, ON 07/21/2000, (ELEVEN DAY AFTER THE RF PROCEDURE ON 07/10/2000), THE PT RETURNED TO THE HOSP DUE TO CHEST PAIN, AN ENDOSCOPY EXAM CONFIRMED DISTAL ESOPHAGEAL ULCER. THE PT STAYED IN THE HOSP UNTIL 07/25/2000 WHEN PT WAS RELEASED UNDER MEDICATION. FOLLOW UP WITH THE CLINICAL COODINATOR ON 10/5/00 CONFIRMED THAT THE PT IS FEELING BETTER. THE REGULATORY AFFAIRS DEPT OF CURON MEDICAL INC. LEARNED OF THIS EVENT ON 9/29/00 AND SHORTLY THEREAFTER FILED THE COMPLAINT WITH FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STRETTA SYSTEM JOS CURON MEDICAL, INC. 4301K FD1058

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization