BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 2960647 · Received February 12, 2013

    Report

    Report Number
    2522801-2013-00001
    Event Type
    Other
    Date Received
    February 12, 2013
    Date of Event
    January 1, 2007
    Report Date
    February 12, 2013
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K041593
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DATE AND THE EXPIRATION DATE OF THIS PRODUCT IS UNKNOWN. NO ITEM OR LOT INFORMATION WAS AVAILABLE; 510(K) #'S FOR CONTOUR THREADS: K041593 - MIDFACE LIFT, K042856 - BROW LIFT, K050247 - NECK LIFT, K050548 - BI-DIRECTIONAL MIDFACE CONTOUR THREAD. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT LOT NUMBER IS UNKNOWN. RESULTS/CONCLUSIONS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, NO PRODUCT EVALUATION CAN BE PERFORMED. ALL CONTOUR THREAD PRODUCT WAS DISCONTINUED IN (B)(4) 2007. ANGIOTECH REFERENCES: (B)(4), UNKNOWN ITEM #, UNKNOWN LOT #, CONTOUR THREADS.

    Description of Event or Problem · 1

    DATE OF EVENT IS ESTIMATED. A PATIENT UNDERWENT A CONTOUR THREAD LIFT PROCEDURE BACK IN 2007. THE PROCEDURE WAS PERFORMED BY DR (B)(6) AT (B)(6). THE PATIENT STATES THAT (B)(6) WEEKS POST PROCEDURE, SHE EXPERIENCED BREAKAGE OF THE PRODUCT. SECONDARY PROCEDURE TO INSERT ADDITIONAL THREADS WAS REQUIRED. THE PATIENT ALSO RECEIVED BOTOX TO FILL IN FACIAL DIMPLING THAT RESULTED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61826 CONTOUR THREAD OR CONTOUR THREADS CONTOUR THREAD OR CONTOUR THREADS GAW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability NONE MADE AVAILABLE