BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TICRON 2-0 WHITE 36" CV-304

    MDR report key: 227397 · Received June 2, 1999

    Report

    Report Number
    1219161-1999-00494
    Event Type
    Malfunction
    Date Received
    June 2, 1999
    Report Date
    May 3, 1999
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE 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 TICRON 2-0 WHITE 36" CV-304 Implant NON ABSORBABLE SYNTHETIC SUTURE GAN UNITED STATES SURGICAL CORP. NA 5K30039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN