BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON II 4-0 27" BEIGE CS-1

    MDR report key: 228292 · Received June 16, 1999

    Report

    Report Number
    2648188-1999-00021
    Event Type
    Malfunction
    Date Received
    June 16, 1999
    Date of Event
    May 12, 1999
    Report Date
    May 18, 1999
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS CO.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN ABDOMINAL HYSTERECTOMY PROCEDURE. REPORTEDLY, THE SUTURE 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 II 4-0 27" BEIGE CS-1 Implant SYNTHETIC ABSORBABLE SUTURE GAN KENDALL HEALTHCARE PRODUCTS CO. NA 965579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN