BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN VENTURI TRANSYSTEM

    MDR report key: 3199240 · Received June 18, 2013

    Report

    Report Number
    3002444944-2013-00001
    Event Type
    Injury
    Date Received
    June 18, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 29, 2013
    Manufacturer
    COPAN ITALIA S.P.A.
    Product Code
    JSL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION REPORT: THE DHR WAS REVIEWED AND NO ANOMALIES HAVE BEEN FOUND DURING ALL THE PRODUCTION STEPS OF THE DIFFERENT PRODUCT COMPONENTS. DEVICE PROBLEM WAS DUE TO THE BREAKAGE OF THE SWAB BEING SEALED BETWEEN TWO PACKAGES. THIS DEFECT IS VISIBLE BY USERS. IT IS STATED ON THE PRODUCT PACKAGE INSERT TO DISCARD PRODUCT THAT IS DAMAGED. VISUAL TEST WAS PERFORMED ON THE RETAINED SAMPLES FROM CLAIMED LOT. OUR INVESTIGATION COULD NOT CONFIRM ANY OTHER MALFUNCTION OR DEFECT IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. NO OTHER COMPLAINTS WERE RECORDED ON THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. EVALUATION OF THE DEVICE THAT CAUSED THE INCIDENT WAS PERFORMED ON PHOTOGRAPHS PROVIDED BY THE USER. (NOTE: THE SAMPLES TESTED WERE COMING FROM THE SAME LARGE LOT NUMBER BUT NOT THE SAME BATCH NUMBER).

    Description of Event or Problem · 1

    THE EVENT OCCURED IN J(B)(6). A SWAB WITHOUT FIBER TIP WAS USED TO COLLECT A SAMPLE FROM THE VAGINA OF A PATIENT. AFTER PROCEDURE, THE DOCTOR NOTICED BLEEDING AND PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276277 COPAN VENTURI TRANSYSTEM JSL COPAN ITALIA S.P.A. 108C.USE E9SV00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention