BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1172666 · Received September 16, 2008

    Report

    Report Number
    2522801-2008-00035
    Event Type
    Other
    Date Received
    September 16, 2008
    Date of Event
    January 1, 2006
    Report Date
    September 16, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAP
    PMA / PMN Number
    K041593-MIDF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K): K042856 - BROW LIFT, K050247 - NECK LIFT, K050548 - BI-DIRECTIONAL MIDFACE CONTOUR THREAD. THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE PRODUCT CODE/LOT IS UNK. NO PRODUCT EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE UNDERWENT A CONTOUR THREAD PROCEDURE TWO (2) YEARS AGO. TWENTY (20) CONTOUR THREADS WERE PLACED BY A DOCTOR. THE PT REPORTS THAT SINCE THE TIME OF THE PROCEDURE, AN AREA ABOVE HIS RIGHT TEMPLE AND AN AREA BEHIND HIS RIGHT EAR HAVE NOT HEALED. BOTH AREAS OCCASIONALLY OPEN AND WILL BLEED. THE PT HAS BEEN SEEING A DERMATOLOGIST FOR TREATMENT OF THESE AREAS. ORAL ANTIBIOTICS AND TOPICAL OINTMENTS HAVE BEEN USED ON MULTIPLE OCCASIONS OVER THE PAST TWO (2) YEARS. THE PT IS SEEKING INFO REGARDING REMOVAL OF THE CONTOUR THREAD. TO DATE, NONE OF THE THREADS HAVE BEEN REMOVED. NOTE: THE CONTOUR THREAD PRODUCT LINE IS NO LONGER MANUFACTURED OR SOLD BY SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR THREAD OR CONTOUR THREADS BARBED THREAD WITH NEEDLE GAP SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE