BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR THREAD

    MDR report key: 863845 · Received June 5, 2007

    Report

    Report Number
    MW5002503
    Event Type
    Injury
    Date Received
    June 5, 2007
    Date of Event
    March 6, 2007
    Report Date
    June 5, 2007
    Manufacturer
    SURGICAL SPECIALTIES CORP
    Product Code
    GAO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DUE TO MY RIGHT EYEBROW BEING LOWER THAN THAT OF MY LEFT BROW I DECIDED TO HAVE A BROW LIFT USING THE CONTOUR THREAD PROCEDURE IN 2007, THIS PROCEDURE FAILED IMMEDIATELY. THEN TEN DAYS LATER, I HAD ANOTHER CONTOUR THREAD PROCEDURE, WHICH FAILED IN 40 MINS. SINCE THE BARBS DID NOT CATCH, THE THREADS MOVE WITHIN MY FOREHEAD AND BROW. FROM TIME TO TIME, THE BARBS ON THE THREAD DO CATCH AND FEEL AS THOUGH SOMEONE IS SAWING INTO MY FOREHEAD OR BROW. THE PAIN BEGINS AS QUICK AND SHARP. ONCE THE TISSUE IS IRRITATED, THE PAIN INTENSIFIES, THEN MY FOREHEAD WILL SWELL AND I AM ABLE TO FEEL WHERE THE THREADS ARE. I AM ASSUMING THE IRRITATION/SWELLING IS WHAT IS CAUSING THE RAILROAD EFFECT ACROSS MY FOREHEAD. THE THREADS ARE VERY THIN. BRIGHT LIGHT AND SUN CAUSE THE PAIN TO INTENSIFY. ONE THREAD DROPPED INTO MY EYELID WHICH I HAVE SINCE HAD REMOVED. I HAVE THIS THREAD IN MY POSSESSION. THERE ARE RISK FACTORS HAVING THE THREADS REMOVED SO I STILL HAVE TWO REMAINING THREADS CAUSING ME PAIN. I WAS GOING TO HAVE A SECOND OPINION WITH ANOTHER PHYSICIAN BUT WHEN I CALLED, THIS PHYSICIAN NO LONGER DID THE PROCEDURE BECAUSE HE HAD REC'D A LETTER FROM THE CO. I DO NOT KNOW THE CONTENT OF THE LETTER, HOWEVER, WITH THE PIN I NOW HAVE AND ONE OF THE THREADS DROPPING INTO MY EYELID, I DECIDED TO DO SOME RESEARCH ON MY OWN. THROUGH THIS, I FOUND MANY OTHER WOMEN ARE HAVING EXACTLY THE SAME COMPLICATIONS WITH THEIR PROCEDURES. I PHONED CLINICAL MGR FOR ANGIOTECH PHARMACEUTICALS, AND HE WILL ASK QUESTIONS TO BENEFIT THEIR CO. HE AVOIDS THE WORK "RECALL". I ASKED ABOUT THE LETTER A PHYSICIAN REC'D YET MY DR NOT RECEIVE ONE. HE DENIED ANY LETTERS ARE BEING SENT OUT BUT HE DID SAY THEY ARE NOW BEGINNING THIS PROCESS. I WOULD RECOMMEND YOU DO NOT ANSWER HIS SPECIFIC QUESTIONS BUT YOU ASK YOUR OWN QUESTIONS. USE CAUTION IF YOU SPEAK TO HIM, HE IS VERY KIND AND PERSUADING TO BENEFIT THEIR RESEARCH. HE WILL BE VERY CONSOLING WITH THE PAIN YOU ARE HAVING. HE WILL LEAD YOU TO BELIEVE THEY WILL REFUND YOUR COSTS OF THE PROCEDURE. IN THE END, ANGIOTECH DOES NOT REFUND YOUR MONEY BUT WILL TELL YOU TO REQUEST THE REFUND FROM YOUR PHYSICIAN. REP SAID THESE NON-ABSORBABLE THREADS ARE NO LONGER BEING MFR BY SURGICAL SPECIALTIES CORP, QUILL MEDICAL, INC WAS SOLD TO ANGIOTECH PHARMACEUTICALS, INC. THIS IS THE CONTACT INFO FOR ANGIOTECH: ANGIOTECH PHARMACEUTICALS, INC. ASK TO SPEAK WITH REP HIS INFO FOR QUILL MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR THREAD CONTOUR THREAD GAO SURGICAL SPECIALTIES CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR