BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1487653 · Received September 23, 2009

    Report

    Report Number
    2522801-2009-00024
    Event Type
    Other
    Date Received
    September 23, 2009
    Date of Event
    January 1, 2007
    Report Date
    September 23, 2009
    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 Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DATE AND THE EXPIRATION DATE OF THIS PRODUCT IS UNK. NO ITEM OR LOT INFO WAS AVAILABLE. THE IMPLANT DATE IS UNK. THE EXPLANT DATES ARE UNK. 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 UNK. RESULTS/CONCLUSIONS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. FURTHERMORE, AS DESCRIBED, THIS PT WAS NOT AN APPROPRIATE CANDIDATE FOR THIS PROCEDURE. PRIMARY COMPLAINT OF EXCESS SKIN WOULD NOT BE RESOLVED WITH THIS MINIMALLY INVASIVE PROCEDURE. ANGIOTECH REF: (B)(4), UNK ITEM #, CONTOUR THREADS.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED: A PT REPORTED THAT SHE UNDERWENT A NECK LIFT PROCEDURE IN 2007 WHERE CONTOUR THREADS WERE USED. PT SUBSEQUENTLY COMPLAINED OF THREAD EXTRUSION, PAIN, INFECTION AT THE EXIT SITES. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE PRODUCT. NOTE - THIS PT WAS NOT AN APPROPRIATE CANDIDATE FOR THIS PROCEDURE. SUBSEQUENTLY, THE PT UNDERWENT A SURGICAL FACELIFT TO REMOVE THE EXCESS SKIN WHICH WAS HER PRIMARY CONCERN. EXCESS SKIN WOULD NOT BE RESOLVED WITH THIS MINIMALLY INVASIVE PROCEDURE.

    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 CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE.