BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KC-RUMI-30

    MDR report key: 3848659 · Received May 29, 2014

    Report

    Report Number
    1627186-2014-00006
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    KOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC IS CURRENTLY INVESTIGATION THE STATED COMPLAINT. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE DEVICE IS RECEIVED BY COOPERSURGICAL INC. THE INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A NEW RUMI USER HAS HAD TWO TIMES A VAGINAL RIP DURING A HYSTERECTOMY PROCEDURE. IN BOTH CASES HE USED 90CC OF SALINE AS RECOMMENDED IN THE MANUAL. HE THINKS THAT FOR WOMEN WITH MENOPAUSE 90 CC OF SALINE IS TOO MUCH AND THAT THIS IS THE CAUSE OF THE VAGINAL RIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316853 KC-RUMI-30 KOH-EFFICIENT KOH COOPERSURGICAL INC. KC-RUMI-30 142908

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention