BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOH CUP

    MDR report key: 1486115 · Received September 23, 2009

    Report

    Report Number
    1216677-2009-00028
    Event Type
    Injury
    Date Received
    September 23, 2009
    Report Date
    September 22, 2009
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN KEEPING WITH GOOD MEDICAL PRACTICE, THE PHYSICIAN IS RESPONSIBLE TO ENSURE ALL NON- IMPLANTABLE DEVICES ARE REMOVED FROM THE PT.

    Description of Event or Problem · 1

    EVENT HAS BEEN REPORTED TO HAVE OCCURRED APPROXIMATELY TWO MONTHS AGO DURING AN LSH. THE PT COMPLAINED OF A VAGINAL DISCHARGE. IT WAS THEN DISCOVERED THE KPH CUP HAD BEEN LEFT IN THE PT. THE KOH CUP WAS REMOVED BY A DIFFERENT PHYSICIAN THAN THE ORIGINAL LSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOH CUP COLPOTOMIZER SYSTEM HEW COOPERSURGICAL, INC. KCP- 30

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention