BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON II 1-0 5X18" BEIGE SC T12

    MDR report key: 297469 · Received September 20, 2000

    Report

    Report Number
    1219161-2000-00870
    Event Type
    Malfunction
    Date Received
    September 20, 2000
    Date of Event
    August 4, 2000
    Report Date
    August 21, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    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 DEVICE WAS USED DURING A HYSTERECTOMY. REPORTEDLY, THE NEEDLE BROKE AND DISENGAGED. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE AND 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 1-0 5X18" BEIGE SC T12 SYNTHETIC ABSORBABLE SUTURE GAN UNITED STATES SURGICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR