BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH AND NEPHEW TRUCLEAR ROTARY MORCELLATOR

    MDR report key: 4101997 · Received September 19, 2014

    Report

    Report Number
    4101997
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 18, 2014
    Manufacturer
    SMITH AND NEPHEW INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE ROOM FOR A TRUCLEAR HYSTEROSCOPY WITH DR. WHILE PERFORMING THE PROCEDURE A SHINY OBJECT WAS NOTED FLOATING IN VISUAL FIELD. THE OBJECT WAS OBTAINED THROUGH SUCTION AND EVACUATED FROM UTERUS PER DR. SMITH AND NEPHEW REPRESENTATIVE, (B)(4), WAS IN ROOM AND ALLERTED OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582767 SMITH AND NEPHEW TRUCLEAR ROTARY MORCELLATOR ROTARY MORCELLATOR HIH SMITH AND NEPHEW INC. 7209509 C43618

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization