BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1025932 · Received April 4, 2008

    Report

    Report Number
    2522801-2008-00010
    Event Type
    Other
    Date Received
    April 4, 2008
    Date of Event
    January 5, 2007
    Report Date
    April 4, 2008
    Manufacturer
    SURGICAL SPECIALTIES (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K050548
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER WAS NOT REPORTED. THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MFG DATE ARE UNK. THE EXPLANT DATE IS ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE DEVICE LOT NUMBER IS UNK. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT HAD A CONTOUR THREAD PROCEDURE IN EARLY 2007. PATIENT DEVELOPED SMALL "KNOTS" ALONG THE THREAD LINE POSTOPERATIVELY. THE CONTOUR THREADS WERE SURGICALLY REMOVED TWO WEEKS AFTER THE INITIAL PROCEDURE. THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC OINTMENT AND HEALED WELL POST REMOVAL. NO LONG TERM INJURY WAS SUSTAINED. NOTE: THE CONTOUR THREAD PRODUCT LINE IS NO LONGER MANUFACTURED OR SOLD BY SURGICAL SPECIALTIES (DBA ANGIOTECH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR THREAD OR CONTOUR THREADS CONTOUR THREAD OR CONTOUR THREADS GAW SURGICAL SPECIALTIES (DBA ANGIOTECH) CT400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention