BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 2562032 · Received April 30, 2012

    Report

    Report Number
    1820334-2012-00197
    Event Type
    Injury
    Date Received
    April 30, 2012
    Date of Event
    December 20, 2011
    Report Date
    April 6, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # NOT PROVIDED BY REPORTER. EXP DATE: UNK AS LOT # IS UNK.(B)(4) - NONRESORBABLE MATERIALS, UNRETRIEVED BODY IS NOT LISTED IN THE INSTRUCTIONS FOR USE. (B)(4) - SEPARATES IS NOT LISTED IN THE INSTRUCTIONS FOR USE. (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PART OF THE WIRE BROKE OFF AND REMAINED IN THE BREAST. THIS WAS NOT APPARENT UNTIL THE PT CAME BACK FOR A 3 MONTHS F/U. THE PIECE HAS NOT BEEN REMOVED FROM THE PT AT THIS TIME. THE PT IS RETURNING FOR A PROCEDURE IN WHICH IT MAY BE POSSIBLE FOR THE SURGEON TO REMOVE THE DEBRIS, BUT IT IS FROM A CERTAINTY THAT THE DEBRIS WILL BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DWO NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other