BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXON 1 36" GREEN T-12

    MDR report key: 286881 · Received July 19, 2000

    Report

    Report Number
    2648188-2000-00055
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    May 18, 2000
    Report Date
    June 20, 2000
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS COMPANY
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE NEEDLE BROKE AND DISENGAGED INTO THE PT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXON 1 36" GREEN T-12 MONOFILAMENT SYNTHETIC SUTURE GAN KENDALL HEALTHCARE PRODUCTS COMPANY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN