BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXON 0 27" GREEN T-12

    MDR report key: 285699 · Received July 12, 2000

    Report

    Report Number
    1219161-2000-00640
    Event Type
    Malfunction
    Date Received
    July 12, 2000
    Report Date
    June 15, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXON 0 27" GREEN T-12 MONOFILAMENT SYNTHETIC SUTURE GAN UNITED STATES SURGICAL CORP. NA 692660H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN