BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON S 3-0 27" BEIGE

    MDR report key: 288706 · Received August 2, 2000

    Report

    Report Number
    2648188-2000-00057
    Event Type
    Malfunction
    Date Received
    August 2, 2000
    Report Date
    July 12, 2000
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS COMPANY
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE NEEDLE BROKE. THE SURGEON APPLIED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON S 3-0 27" BEIGE SYNTHETIC ABSORBABLE SUTURE GAN KENDALL HEALTHCARE PRODUCTS COMPANY NA 982611

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN