BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1047961 · Received May 15, 2008

    Report

    Report Number
    2522801-2008-00017
    Event Type
    Other
    Date Received
    May 15, 2008
    Date of Event
    April 17, 2006
    Report Date
    May 15, 2008
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT INDICATED THAT SOME OF THE CONTOUR THREADS HAVE BEEN EXPLANTED. HOWEVER, THE EXPLANT DATE WAS NOT PROVIDED. THE 510 (K) #'S FOR CONTOUR THREADS: K042856- BROW LIFT, K050247- NECK LIFT, K050548- BI-DIRECTIONAL MIDFACE CONTOUR THREAD. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT MODEL # AND LOT # IS UNK. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE UNDERWENT A FULL FACE CONTOUR THREAD PROCEDURE (I.E., FACE LIFT) TWO (2) YEARS AGO. THE PROCEDURE WAS PERFORMED BY A DOCTOR AND INITIALLY, SHE WAS PLEASED WITH THE RESULTS. AS TIME WENT ON, HOWEVER, THE THREADS BEGAN TO BREAK. SEVERAL THREADS WERE REMOVED FROM HER NECK AND REPLACED; BUT THE NEW THREADS ALSO BROKE. MULTIPLE THREADS REMAIN IN HER FACE AND MOST OF THEM ARE NOT BOTHERSOME. HOWEVER, THE THREADS IN HER FOREHEAD HAVE CAUSED BUMPS IN HER HAIRLINE, FORM "PIMPLES" AND DRAIN. THE PT STATED THAT SHE WOULD LIKE TO HAVE ALL REMAINING THREADS REMOVED FROM HER FACE BUT IS NOT COMFORTABLE WITH THIS DOCTOR PERFORMING THE PROCEDURE. NOTE: THE CONTOUR THREAD PRODUCT LINE IS NO LONGER MANUFACTURED OR SOLD BY SURGICAL SPECIALITIES.

    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