BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR THREAD OR CONTOUR THREADS

    MDR report key: 1081175 · Received May 30, 2008

    Report

    Report Number
    2522801-2008-00018
    Event Type
    Other
    Date Received
    May 30, 2008
    Date of Event
    October 11, 2005
    Report Date
    May 30, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT INDICATED THAT INTERVENTION WILL BE NEEDED TO REMOVE THE THREADS. HOWEVER, REMOVAL OF THE CONTOUR THREADS HAS NOT BEEN UNDERTAKEN AT THIS POINT. MIDFACE LIFT. BROW LIFT. NECK LIFT. BI-DIRECTIONAL MIDFACE CONTOUR THREAD. THE DEVICE WAS NOT RETURNED FOR EVAL. FURTHERMORE, THE PRODUCT CODE/LOT IS UNK. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    ANGIOTECH FIRST BECAME AWARE OF THIS EVENT ON 5-MAY-2008 FROM A LETTER SENT BY THE FDA. THE PT REPORTED THE EVENT USING THE FDA'S MEDWATCH PROGRAM. REFER TO THE MAUDE EVENT REPORT FOR A COMPLETE DESCRIPTION. NO PT, DOCTOR OR SPECIFIC PRODUCT IDENTIFYING INFO WAS PROVIDED. THE PT REPORTED THE FOLLOWING: I CONTRACTED A PLASTIC SURGEON TO PERFORM A "MINI FACE LIFT EFFECT" USING CONTOUR THREADS" TO CORRECT "MINOR JOWL AND NASAL/LABIA FOLD AGING." THREE (3) MONTHS POSTOPERATIVELY, THE SWELLING HAD REDUCED AND I NOTICED A "DENT" IN MY RIGHT CHEEK THAT WAS NOT THERE PRIOR TO THE SURGERY. THE INCISION AREA IN MY TEMPLES WHERE THE THREADS WERE ATTACHED HAS NEVER STOPPED HURTING. PERIODICALLY, THE THREADS PROTRUDE FROM MY CHEEKS NEAR MY UPPER LIP AND TO THE SIDE OF MY NOSE IN A PAINFUL "PUS FILLED PIMPLE." THE THREADS RECEDE AFTER ABOUT THREE (3) TO FIVE (5) DAYS BUT ALWAYS COME BACK OUT. REMOVAL OF THE CONTOUR THREADS" HAS NOT BEEN UNDERTAKEN AT THIS POINT. NOTE: THE CONTOUR THREAD PROD LINE IS NO LONGER MFG OR SOLD BY SURGICAL SPECIALTIES CORP (DBA ANGIOTECH).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention