BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXON 3-0 27" GREEN T-5

    MDR report key: 226710 · Received June 3, 1999

    Report

    Report Number
    2648188-1999-00017
    Event Type
    Malfunction
    Date Received
    June 3, 1999
    Date of Event
    April 28, 1999
    Report Date
    May 7, 1999
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS COMPANY
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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 HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXON 3-0 27" GREEN T-5 Implant MONOFILMENT SYNTHETIC SUTURE GAN KENDALL HEALTHCARE PRODUCTS COMPANY NA 966597

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN