[114504825]
On sunday (b)(6) 2018, we experienced a traumatic situation whereas our son (b)(6) inhaled his lower retainer. This situation was: our family was headed to (b)(6) for the evening around 6pm for dinner. On the way, ((b)(6)), (b)(6) was sitting quietly in the back seat of our truck, watching a video on his phone. All of a sudden, he began choking. (b)(6) ((b)(6) mother) who was in the passenger front seat, immediately jumped back in our truck to help him start breathing again. He was displaying the sign of choking, with his hands around his neck, and he was not able to get air into his airway. As soon as (b)(6) was able to sit upright, after flying head first to the back of the truck, she recognized he was able to breathe, and (b)(6) was able to share with us that he swallowed his retainer. (when arriving at the hospital, we shared with the staff, we thought he inhaled it. But, they honestly, could hardly believe it. ) thankfully, by the grace of god, within 30 seconds to a minute, he was able to breathe after ingesting the retainer. Then we flew to the quickest emergency setting. Obviously, panic had set in. The realization of the fire department not being staffed, because we just drove by the fire department was ominous. At that point, we knew we had either the option to call 911 or go to (b)(6) hospital. Since (b)(6) was breathing and talking to us, we knew we were less than a few miles away, and we drove as fast as we could to get emergency care. Once at (b)(6) hospital, (b)(6) was immediately seen in er, had several x-rays, and a ct scan. The results were (b)(6) aspirated his retainer, and the retainer was lodged in his lung area (by his left bronchi). It was shared with us that the retainer was in a dangerous spot and that if it had moved, it could be more dangerous than its position at that time. Thankfully, the staff at (b)(6) hospital created a treatment plan with (b)(6). This treatment plan involved transporting (b)(6) to the children's hospital, and evaluating him there. It was shared with us that (b)(6) could have been aero meded by the helicopter, if his airway would have been blocked off. This medical device caused extreme trauma for our whole family. Our (b)(6) son (b)(6) was watching his brother go through an unbelievable traumatic event. Also, we could not believe that our son could be tragically injured by a dental appliance. Well, once they gathered all the information they needed, a treatment plan was formed, and (b)(6) ambulance arrived, (b)(6) was transported by ambulance. (b)(6)-(mother) and (b)(6)-(patient) went in the ambulance and (b)(6)-(brother) and (b)(6)-(father) followed. This was one of the longest drives our whole family has ever experienced, even only 30 or so miles. The ride was excruciating for all of us because we were concerned about the size of the retainer - it fits around the quarter. Also, the possible movement within in the body causing (b)(6) to have further breathing damage or causing death. As our doctors described the situation as a life and death situation, as it was a trauma and needed immediate attention. Once we arrived at (b)(6) after 10pm, he went into surgery and the retainer was removed. (b)(6) recovered and was sent home for rest, on prednisone. The issues and concern herein, is the size of retainer pictured as exhibit a. As this retainer provided to us by drs. (b)(6) and (b)(6) orthodontics was small enough to cause a choking or swallowing hazard and frankly should not be given to children. This retainer could easily be released from the teeth and be a loose foreign object in the mouth cavity, thereby if a person swallow or inhales, as (b)(6) did, could result in permanent damage or death to the person. Needless to say, the orthodontist practice has offered to cover all expenses as a result of this situation. However, our additional concern is what if there is a residual damage post-surgery. Moreover, what if there are other children that have a small retainer like (b)(6) who are at risk of a similar situation or worse death if this were to happen to them. In fact, what if this happened while (b)(6) was sleeping, and we did not know it, that damages could have been far worse and possibly terminal. We are truly concerned about the doctor's telling us this is a text book retainer, and this medical device is safe. We have reached out to a dentist and an orthodontist, and it has been shared with us that the use of this type of retainer is frowned upon because it is a clear choking hazard. As parents, we 100% agree. The issues we have with this medical device is: it can wrap around a quarter. It is way too small to be in a person's mouth. Please place a quarter in your hand. (see exhibit a) you will see this dental appliance is way too small, and patients could choke on it. This dental appliance easily fits into a specimen cup, which is how small it is; (see exhibit b) they did not place metal hooks to clip on to the back of the teeth, like lower retainers do. If these hooks would have been on this appliance, (b)(6) could have grabbed it; they did not add sufficient acrylic to the dental appliance, so it would not be a choking device. The device is way too tiny, and there needed to be more bulk to the appliance. When questioning the orthodontist about where the retainer was produced, dr. (b)(6) initially avoided the question, and after pursuing the question further, he admitted they produced the retainers in their own laboratory within their (b)(6) practice. This is concerning as this may not be fda approved and they may be producing retainers that are dangerously too small for children and/or adults to have in their mouth cavity. We were unable to add the rest of our documents of the letter. We added it here: we are so thankful for the staff at (b)(6) hospital, (b)(6) ambulance and (b)(6) hospital. Everyone was outstanding and so helpful and caring! (b)(6) and i thank god for being there with (b)(6), and continue to heal (b)(6). (b)(6) is home with us, very sore, but in good spirits. However, he has experienced a traumatic event. He is telling us he does not want to return to this orthodontist, and he is just beginning to sleep in his own room again. Tonight, he began crying because he saw an ambulance drive by. Our entire family has been breaking down, thinking we could have lost our handsome (b)(6) son. We just do not want to see this happen to any other family. It has been extremely traumatic and could have been tragic for our family. Finally, we did request the orthodontist office to file a mandatory medwatch report. They did not appear to be aware of this report, but we did request that they do this. Since the trust has been lost with this orthodontic practice, we will no longer be receiving assistance from them. So we decided it was important to file the voluntary medwatch report. We hope and pray that this type of medical device is not allowed in the future. We would feel so bad if a child lost their life because of it. Thank you for reviewing our concerns. If you have any further questions, we would love to assist. Thank you, (b)(6). In addition, we have pictures of exhibit a and exhibit b to show the retainer, but we were unable to submit them on this document. The retainer fits around a quarter and does not have adequate acrylic to prevent choking. The dental staff that we have shared this with after this incident, are amazed that this would be placed in someone's mouth. We would love to share these exhibits with someone.
Patient Sequence No: 1, Text Type: D, B5