BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOH-EFFICIENT, RUMI 3.0CM

    MDR report key: 3181405 · Received June 14, 2013

    Report

    Report Number
    1627186-2013-00006
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 14, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED KOH EFFICIENT IS CURRENTLY STILL UNDER INVESTIGATION BY OUR QUALITY ASSURANCE DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A HYSTERECTOMY. WHEN THE PHYSICIAN PULLED OUT THE KOH-EFFICIENT, SHE NOTICED LACERATIONS ON THE VAGINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272005 KOH-EFFICIENT, RUMI 3.0CM NONE KOH COOPERSURGICAL, INC. 139842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention