BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON S 3-0 27" BEIGE

    MDR report key: 288708 · Received August 2, 2000

    Report

    Report Number
    1219161-2000-00732
    Event Type
    Malfunction
    Date Received
    August 2, 2000
    Report Date
    July 12, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    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 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 UNITED STATES SURGICAL CORPORATION NA 984226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN