[172032]
Complainant's child has misshapen head as well as torticollis. Complainant asked ballert orthopedic, chicago, il, if they were "fda approved". Firm replied that they were fda approved. Complainant contracted with firm to manufacture & fit child with a cranial helmet to treat their medical condition. The cranial helmet was manufactured with improper specifications and required patching. Patching caused red marks to appear on child's forehead. Firm told complainant that they were misinformed by one of co's employees & that they were not fda approved but the device did not require fda approval because it was not an "invasive orthotic". Complainant feels that a great injustice has been done. Complainant has requested registration, listing, & 510(k) info from fda regarding ballert orthopedic & cranial technologies so they can inform their insurance co. Field officer sent info from fda's website. Field officer will also send complainant a copy of the medwatch form fda-3500 as per iom 927. Rptr writes: "i am writing this letter to inform" fda "of a great injustice that has happened to me and my" child. Child "has a misshapen head as well as torticollis. Child has seen a pediatric neurosurgeon. "... "i was elated to get the referral & eager to get the cranial band put on as soon as possible due to" child's "age and the torticollis. To my dismay, my insurance carrier"... "denied my referral claiming that the band was "investigational". I had decided that i would appeal this decision because after doing my research, i learned that cranial technologies was fda approved, and it was of the utmost importance to me. Because of the fact that my child was young and because of the aforementioned factors, detailing the critical importance of the immediate initiation of cranial banding therapy, i decided on 2/11 to call ballert orthopedic. An insurance co did approve svs for this office. I called the mfr's office which is then transferred to the main office. I asked the receptionist to direct me to the person who can give me info about the cranial helmet. "... "i spoke with" mfr "and explained my concerns about facility not being fda approved for the cranial helmet and they assured me that they were. I was perfectly clear about specifying my concerns about the helmet and my respect for the fda. After they assured me that ballert orthopedics was fda approved for the cranial helmet i scheduled an appointment. I felt confident of this facility since it was fda approved and made the appointment for that same day at 1:00 pm. At that point i decided not to appeal my hmo's decision. I brought my" child "back to ballert orthopedics"... "to pick up helmet. I was upset to find out that they made a mistake on the helmet. They put the holes to view my" child's "flat spots on the wrong side. At that point i became concerned about the quality of this office. In my opinion, this was a major mistake. The orthotist"... "did not notice this for about ten mins after they had filed down the helmet and discovered something was wrong. They decided to put a patch over the spot that the holes were not supposed to be at and sent us home. It took approx one hr to get home, at that time i took the helmet off and discovered a two inch circle on" my child's "forehead, where the patch was placed. The red mark stayed there for about an hr and a half. I immediately called the office to notify the orthotist about the problem, they rescheduled my" child "to come back. At the fitting of the helmet i felt rushed. My appointment was at 1 pm and i had to wait outside for" the orthotist "to open up the office. Then while i was there" they "saw another pt briefly for about a half hour and then proceeded with the filing of the helmet. At that point, when" they "felt that the helmet was okay" they "said i can go home and to check the helmet in two hrs. I actually wanted to stay there for about a half hour or more to see if there were any problems but" they "informed me that i was" the "last pt and i felt rushed to leave. I did not feel confident with ballert orthopedic. Because of my worries of my cranial helmet with ballert orthopedics it was brought to my attention that they were not fda approved. I insisted that they were because i did get a verbal verification"... "so when i went to ballert"... "to fix the helmet i asked"... "about my concerns about them not being fda approved for the cranial helmet and" they "confirmed my concerns that they were not fda approved for the cranial helmet. " they "continued to tell me that it does not have to be fda approved because it was not an invasive orthotic. This was very disturbing to me and i explained that i spoke with a" person at their co, who "assured me the cranial helmet was approved". They "said that they did put an application in to the fda 3 weeks ago and that it is a long process that has not been resolved. I told" the orthotist "that i was specific about my concerns about the cranial helmet being fda approved, and they said, well" the rep "misled you. On that day, my appointment was for 9:30 am, i did come 10 mins late. " the orthotist "did work on my" child's "helmet, fixing the spots that made" my child's "head very red. It was 10:30 am and i could tell that they were rushed, i again apologized for being ten mins late and asked if they had another pt soon. " they "stated that" they "had a dental appointment across the hall at ten o'clock. " they "then said that i was finished and to come back next week. My concern at this time was that i would get all the way home and take the helmet off and it would be red for quite some time. I asked if i could go outside the office and wait for them to come back from their appointment because i was worried about how the helmet was fitting after one hr. They said that they did not know how long it would be. I told them that i could go shopping down the street but i could tell they were not interested. So there it goes again, i felt that i was rushed. Cont. B6
Patient Sequence No: 1, Text Type: D, B5