Description of Event or Problem · 1
PT WAS WEARING ORTHODONTIC HEADGEAR. AS THEY WERE REMOVING IT FROM THEIR MOUTH, IT SLIPPED FROM THEIR HANDS. BECAUSE THE HEAD RESTRAINT WHICH PROVIDES TENSION TO THE DEVICE WAS STILL ON PT'S HEAD, THE RESULT WAS SIMILAR TO THAT OF A SLING SHOT OR CROSSBOW. THE THIN METAL PRONGS FROM THE MOUTHPIECE SHOT BACK AT PT WITH GREAT VELOCITY PIERCING BOTH EYES. THIS RESULTED IN EXTREME TRAUMA TO BOTH EYES. AS OF NOW, PT WILL HAVE DIMINISHED VISION IN THEIR LEFT EYE AND POSSIBLE BLINDNESS IN THE RIGHT EYE. PT RECEIVED THE HEADGEAR JUST FIVE DAYS EARLIER. PARENT WAS PRESENT WHEN THE ORTHODONTIST'S ASSISTANT SHOWED PT HOW TO PUT ON AND REMOVE THE HEADGEAR. THERE WAS NO CONVERSATION AS TO THE POTENTIAL DANGERS IF THE HEADGEAR WAS REMOVED INCORRECTLY. THERE WAS NO EMPHASIS ON THE IMPORTANCE OF REMOVING IT ONLY A CERTAIN WAY. THERE WAS NO WARNING LABEL ON THE HEADGEAR, IT IS CLEARLY A "WEAPON", NOR WAS THERE ANY LITERATURE PROVIDED OUTLINING THE POSSIBLE SAFETY HAZARDS IF REMOVED INCORRECTLY. PARENT STRONGLY URGES THE FDA TO REQUIRE THE MFRS OF THESE DEVICES TO ATTACH WARNING LABELS AS WELL AS INCLUDE A SAFETY PAMPHLET WHICH OUTLINES THE SERIOUS DANGERS OF THESE DEVICES IF REMOVED INCORRECTLY. THEY URGE DIAGRAMS BE INCLUDED TO SHOW CHILDREN AND PARENTS THE "CORRECT" WAY TO REMOVE THE DEVICE AND THE "INCORRECT" WAY. THEY URGE THE ORTHODONTIC COMMUNITY BE REQUIRED TO TELL THEIR PTS ABOUT THE HAZARDS INVOLVED IF THE HEADGEAR IS INCORRECTLY REMOVED. IN PARENT'S PRELIMINARY RESEARCH, THEY HAVE FOUND STATISTICS REGARDING INJURY DUE TO IMPROPER HEADGEAR USE. YET, THEY HAVE SEEN ONLY ONE ORTHODONTIST'S WEBSITE WHICH STRONGLY EMPHASIZED AND OUTLINED THE EXTREME DANGERS OF IMPROPER HEADGEAR USE. ALL OTHER WEBSITES THUS FAR HAVE ONLY SPOKEN ABOUT THE USE OF HEADGEAR AS A TOOL USED TO IMPROVE THE PT WITH THEIR ORTHODONTURE PROGRAM. PARENT'S QUESTION IS SIMPLE. IF THERE ARE STATISTICS ON HEADGEAR INJURIES, THEN WHY IS THIS INFO NOT PASSED ON TO THE "CONSUMER"? THE "CONSUMER" PRIMARILY BEING YOUNG CHILDREN. PARENT QUESTIONS WHY ORTHODONTISTS AREN'T EDUCATING THEIR STAFF AND THEIR PTS ABOUT THE SERIOUS RISKS INVOLVED IF A CHILD ERRONEOUSLY REMOVES THE HEADGEAR AND WHY THE MFRS AREN'T PUTTING LABELS ON THESE DEVICES AND PROVIDING THE PROPER LITERATURE TO ENSURE ITS SAFE USE. PARENT FEELS IF THEIR CHILD AND THEY WERE EDUCATED AND INFORMED ABOUT THE SERIOUS HAZARDS INVOLVED AND THE POSSIBLE RISK OF INJURY OF THE HEADGEAR WAS NOT REMOVED PROPERLY, THEN PT WOULD HAVE AVOIDED SUCH A TRAGEDY. PARENT REQUESTS HELP TO ENSURE THAT ANOTHER CHILD DOES NOT SUFFER THE SAME FATE.