BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPT SYSTEMS, INC

    MDR report key: 958662 · Received November 30, 2007

    Report

    Report Number
    MW5004589
    Event Type
    Injury
    Date Received
    November 30, 2007
    Report Date
    November 30, 2007
    Manufacturer
    *
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE SERIOUS ADVERSE AFFECT AT PRESENT WITH TISSUE PLACEMENT DEVICES MADE BY COAPT. MAKERS OF POLYGLYCOLIC ENDOTINES, AND ULTRATINES THAT ARE SUPPOSED TO BE ABSORBED BY THE BODY OVER WHAT I WAS TOLD JUST A FEW WEEKS. MYSELF AND MANY OTHERS HAVE ENCAPSULATION AROUND THE ENDOTINES THAT REQUIRE "SMASHING OR CRUSHING" VERY PAINFUL I MIGHT ADD AND KENALOG STEROID SHOTS TO MAKE THEM DISSOLVE, BECAUSE THEY DON'T FOR OVER A YEAR IF THAT. I WAS NEVER TOLD ABOUT THEIR INSTALLATION PRIOR TO MY ENDOSCOPIC BROW LIFT. AFTER MY SURGERY, I SAW THESE TRIANGLES ON MY HEAD AND MY PS SAID THAT THEY WERE LIKE VELCRO AND WOULD BE GONE IN 10 WEEKS. IT HAS BEEN 10 MONTHS, AND I STILL HAVE PAIN, SWELLING, NUMBNESS, BLURRED VISION, AND I AM GROWING HORNS LIKE A REINDEER ON MY BROW. MY ATTORNEY ADVISED ME TO CONTACT THE FDA. I HAVE GONE TO THE MEDIA, AND I WOULD LIKE YOUR HELP IN PREVENTING THESE DEVICES, WHICH TAKE FOREVER TO GO AWAY, NOT TO MENTION THE PAIN, DISCOMFORT, DEPRESSION, FROM BEING USED IN BROW LIFTS. THEY DO NOT DISSOLVE!!! I AM BLOGGING WITH OTHERS WHO ARE JUST LIKE ME, SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPT SYSTEMS, INC ULTRATINE OR ENDOTINE MAI * ULTRATINE FOREHEAD 01466

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| S