BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KC-ARCH-40

    MDR report key: 3812633 · Received May 7, 2014

    Report

    Report Number
    1216677-2014-00006
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT WAS SEEN IN THE HOSPITAL'S EMERGENCY DEPARTMENT WITH COMPLAINTS OF SEVERE ABDOMINAL PAIN. AFTER ASSESSING THE PATIENT, IT WAS DETERMINED THAT THE PATIENT HAD A KOH-CUP INSIDE OF HER. THE PATIENT REPORTED THAT SHE HAD UNDERGONE A HYSTERECTOMY PROCEDURE IN (B)(6) OF 2013 AT THE SAME HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276022 KC-ARCH-40 KOH-EFFICIENT, ARCH 4.0 CM KOH COOPERSURGICAL, INC. KC-ARCH-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention