BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR THREADS

    MDR report key: 661936 · Received November 25, 2005

    Report

    Report Number
    MW1037619
    Event Type
    Malfunction
    Date Received
    November 25, 2005
    Date of Event
    August 13, 2005
    Report Date
    November 25, 2005
    Manufacturer
    SURGICAL SPECIALTIES CORP
    Product Code
    GAP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT - CONTOUR THREADS - POLYPROPYLENE, BARBED, SUTURE THREADS USED FOR EVALUATION AND FIXATION OF MIDFACE, BROW AND/OR NECK. PT HAD 4 THREADS INTRODUCED ON EACH SIDE OF FACE. AFTER HEALING AND FOR A PERIOD OF 45 DAYS, RESULTS WERE SATISFACTORY. HOWEVER, POSITIVE RESULTS ARE RAPIDLY DIMINISHING. RPTR WAS TOLD, BY PHYSICIAN, MANUFACTURER'S REP AND MANUFACTURE LITERATURE, THAT THE MID-FACE "LIFT" EFFECTS WOULD BE APPARENT FOR 3-5 YEARS. AT THIS RATE, EFFECTS WILL BE COMPLETELY GONE WITHIN ONE YEAR. CONSULTED SEVERAL OTHER PRACTITIONERS, IN PERSON AND ONLINE, AND WAS TOLD BY THEM THAT CONTOURTHREADS "DO NOT LAST AS PURPORTED AND ADVERTISED BY MANUFACTURER". FURTHERMORE, THOSE PRACTITIONERS SAID THAT THEY NO LONGER PERFORM THAT "THREADLIFT" PROCEDURE USING THE CONTOUR THREAD PRODUCT. PT BELIEVES SURGICAL SPECIALTIES CORP IS PERPETRATING FRAUD TO PHYSICIANS AND THEIR CLIENTS. ONLY RECOURSE IS TO UNDERGO ANOTHER PROCEDURE WITH A DIFFERENT PRACTITIONER WHO USES MORE EFFECTIVE THREADS WITH A HISTORY OF EFFECTIVENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR THREADS CONTOUR THREADS GAP SURGICAL SPECIALTIES CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other