BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EURO-MED

    MDR report key: 833726 · Received March 29, 2007

    Report

    Report Number
    1216677-2007-00007
    Event Type
    Injury
    Date Received
    March 29, 2007
    Date of Event
    January 1, 2006
    Report Date
    March 29, 2007
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, THE SUBJECT INSTRUMENT HAS NOT BEEN RETURNED. UPON RECEIPT, THE EVAL WILL COMMENCE AND THE REPORT SUPPLEMENTED. CROSS REFERENCE COMPLAINT 0307-089 AND MDR 1216677-2007-00006.

    Description of Event or Problem · 1

    DURING A COLPOSCOPY AND BIOPSY, A TISSUE SAMPLE WAS TAKEN RESULTING IN THE PT BEING SUTURED TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO-MED MINI-UP ROTATING BIOPSY TIP KNW COOPERSURGICAL, INC. 64-651 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention