BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOLDENBERG SNARECOIL

    MDR report key: 476431 · Received July 31, 2003

    Report

    Report Number
    MW1029194
    Event Type
    Other
    Date Received
    July 31, 2003
    Date of Event
    July 7, 2003
    Report Date
    July 31, 2003
    Manufacturer
    KENDALL CO.
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 2 INCH GOLDENBERG SNARECOIL BONE MARROW BIOPSY NEEDLE BROKE OFF INTO THE PT'S LEFT ILIAC CREST DURING A BONE MARROW BIOPSY. APPROXIMATELY 0.5 INCH OF METAL REMAINED IN THE PT WHEN THE NEEDLE WAS EXTRACTED. THE RETAINED PIECE COULD NOT BE EXTRACTED WITHOUT SURGERY, WHICH IS NOT FEASIBLE SINCE THE RISK OUTWEIGHS THE BENEFIT -THE PT IS TOO ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDENBERG SNARECOIL BONE BIOPSY NEEDLE FCG KENDALL CO. SC2013X *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other