BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEK BL MF 8-0 XT-7 2N 24"X2 SP

    MDR report key: 440889 · Received January 28, 2003

    Report

    Report Number
    1221601-2003-00001
    Event Type
    Other
    Date Received
    January 28, 2003
    Report Date
    January 28, 2003
    Manufacturer
    GENZYME BIOSURGERY, A DIVISION OF GENZYME CORP.
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE ALLEGEDLY BROKE WITHOUT BEING UNDER TENSION, IN "MID-AIR" ACCORDING TO THE DOCTOR. ADD'L INFO RECEIVED INDICATED THE SURGEON WAS SEWING THE MAMMARY ARTERY AND THE SUTURE ALLEGEDLY BROKE IN THE MIDDLE. THE CUSTOMER REPORTED THERE WAS NO EXCESSIVE TENSION ON THE SUTURE. THE INSTRUMENTS USED FOR SEWING WERE A JACOBSON NEEDLE HOLDER, AND RING GERALD FORCEPS. MEDWATCH REPORT WAS RECEIVED FROM THE CUSTOMER IN 01/2003 ALLEGING THAT THE REPORTED PRODUCT FAILURE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEK BL MF 8-0 XT-7 2N 24"X2 SP * GAO GENZYME BIOSURGERY, A DIVISION OF GENZYME CORP. D-7504M2 508504

    Patients

    Seq Age Sex Outcome Treatment
    1 *