BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 818926 · Received February 10, 2007

    Report

    Report Number
    818926
    Event Type
    Injury
    Date Received
    February 10, 2007
    Date of Event
    October 11, 2006
    Report Date
    February 6, 2007
    Manufacturer
    UNK
    Product Code
    OJF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS OUTPATIENT WAS UNDERGOING A D&C, HYSTEROSCOPY WHEN THE SHARP CURETTE WAS PASSED, IT WENT DEEPER INTO THE ENDOMETRIAL CAVITY THAN EXPECTED BASED ON THE HYSTEROSCOPY THAT HAD BEEN DONE PRIOR. THE CURETTE WAS REMOVED AND THE HYSTEROSCOPE RE-INSERTED, A PERFORATION OF THE UTERUS WAS NOTED. THE AREA WAS HEMOSTATIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND MONITORING OF BLOOD COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SHARP CURETE OJF UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization