BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 3683110 · Received February 25, 2014

    Report

    Report Number
    2522801-2014-00002
    Event Type
    Injury
    Date Received
    February 25, 2014
    Date of Event
    January 1, 2006
    Report Date
    February 24, 2014
    Manufacturer
    SURGICAL SPECIALITIES CORP
    Product Code
    GAW
    PMA / PMN Number
    K050548
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DATE AND THE EXPIRATION DATE OF THIS PRODUCT IS UNK. NO ITEM OR LOT INFORMATION WAS AVAILABLE. THE 510(K) NUMBERS FOR CONTOUR THREADS: K041593 - MIDFACE LIFT, K042856 - BROW LIFT, K050247 - NECK LIFT, K050548 - BI-DIRECTIONAL MIDFACE CONTOUR THREAD. PT: LOCAL AND POSSIBLE SYSTEM INFECTION REPORTED. DEVICE: MINOR SPITTING OF THE SUTURE MATERIAL ALONG HAIRLINE / FOREHEAD AND BEHIND EAR WAS REPORTED. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT ITEM AND LOT NUMBER IS UNK. 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. SURGICAL SPECIALITIES REFERENCES: COMPLAINT #(B)(4). UNK ITEM NUMBER, UNK LOT NUMBER, CONTOUR THREADS.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. DR. (B)(6), RELATIVE OF THE PT, REPORTED THAT THE PT RECEIVED A FACE LIFT IN 2006 WHERE MULTIPLE CONTOUR THREAD DEVICES WERE UTILIZED. THE PT HAS SINCE EXPERIENCED LOCAL INFECTION AND POSSIBLE SYSTEM INFECTION AT DIFFERENT PERIODS SINCE THE DEVICES WERE IMPLANTED. THE PT HAS ALSO EXPERIENCED MINOR SPITTING OF THE SUTURE MATERIAL ALONG HER HAIRLINE/FOREHEAD AND BEHIND HER EAR. DETAILS REGARDING THE PT'S HEALTH HISTORY AT TIME OF THE SURGERY, INITIAL PROCEDURE, TECHNIQUE OF THE SURGEON AND / OR POST-OPERATIVE INTERVENTION WAS NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115706 CONTOUR THREAD OR CONTOUR THREADS CONTOUR THREAD OR CONTOUR THREADS GAW SURGICAL SPECIALITIES CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE