BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EURO-MED

    MDR report key: 936428 · Received November 1, 2007

    Report

    Report Number
    1216677-2007-00028
    Event Type
    Injury
    Date Received
    November 1, 2007
    Report Date
    November 1, 2007
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    EME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT INSTRUMENT WAS PURCHASED IN 2006. THE INSTRUMENT WAS RETURNED TWICE FOR SHARPENING, IN 2007. THE INSTRUMENT WAS RETURNED WITH REGARDS TO THIS REPORT. THE INSTRUMENT WAS FOUND TO BE DULL. IT IS NOT KNOWN HOW MANY TIMES THE INSTRUMENT WAS USED TO DETERMINE IF PREMATURE DULLING OF THE CUTTING SURFACE OCCURRED.

    Description of Event or Problem · 1

    DURING A CERVICAL BIOPSY/COLPOSCOPY, A TISCHLER MORGAN BIOPSY PUNCH WAS UTILIZED TO ACHIEVE A SAMPLE. THE BIOPSY PUNCH CUT THROUGH APPROX 75% AND THE REST WAS PULLED OFF. THE PT WAS UNCOMFORTABLE AND IN PAIN. EXCESS BLEEDING OCCURRED. THE BLEEDING WAS STOPPED USING CAUTERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO-MED BIOPSY PUNCH EME COOPERSURGICAL, INC. 64-689

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention