BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON II 1-0 5X18" BEIGE SC T12 DETACH

    MDR report key: 292968 · Received August 23, 2000

    Report

    Report Number
    2648188-2000-00060
    Event Type
    Malfunction
    Date Received
    August 23, 2000
    Date of Event
    June 13, 2000
    Report Date
    July 24, 2000
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS COMPAN
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COMPLETE THE PROCEDURE WITHOUT ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON II 1-0 5X18" BEIGE SC T12 DETACH SYNTHETIC ABSORBABLE SUTURE GAN KENDALL HEALTHCARE PRODUCTS COMPAN NA 981764

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR