BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1024693 · Received April 3, 2008

    Report

    Report Number
    2522801-2008-00006
    Event Type
    Other
    Date Received
    April 3, 2008
    Date of Event
    January 1, 2005
    Report Date
    April 3, 2008
    Manufacturer
    SURGICAL SPECIALTIES (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K041593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) #'S FOR CONTOUR THREADS: K042856 - BROW LIFT, K05247 - NECK LIFT, K050548 - BI-DIRECTIONAL MIDFACE CONTOUR THREAD. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT CODE/LOT IS UNK. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. (B) (4).

    Description of Event or Problem · 1

    PT HAD A BROW AND MIDFACE CONTOUR THREAD PROCEDURE IN 2005. FOLLOWING THE SURGERY, THE PT REPORTS EXPERIENCING PAIN IN THE BROW AREA, EXTRUSION OF THREADS, SCARRING ALONG THE THREAD PATH AND THE THREADS ARE VISIBLE UNDER THE SKIN. SEVERAL OF THE THREADS HAVE BEEN REMOVED AND THE PT IS SEEKING ASSISTANCE WITH THE REMOVAL OF THE REMAINING THREADS. NOTE: THE CONTOUR THREAD PRODUCT LINE IS NO LONGER MANUFACTURED OR SOLD BY SURGICAL SPECIALITIES (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) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention