[47802757]
My son, (b)(6), was referred by pt on (b)(6) 2016 to obtain a cranial scan for possible need of cranial remolding helmet due to worsening deficit in head measurements, despite repositioning and therapy for torticollis. Appointment was scheduled for (b)(6) 2016 and scan was completed that day by (b)(6). I called several times over the coming weeks to check on order and progress in starting therapy. Was called by company on the week of may 30-june 3rd (not sure of date); and was told that they had received insurance approval and were placing order for helmet. I asked at that time if we needed to rescan his head due to lapse in time, i was told "no" by staff. My son started cranial remolding helmet therapy on (b)(6) 2016, the device did not harm him, but i felt that it was not fitting properly. Returned to (b)(6) office on 06/09/2016 and requested that areas to left ear and right forehead be adjusted (shaved down) due to redness not resolving within 1 hour and he was unable to open right eye fully due to helmet. Was told by orthotist on (b)(6) 2016 to expect some bruising and redness, that it was normal. I specifically asked her if she has had any cases which resulting in pressure ulcer development, was told no. We continued the recommended schedule for helmet for (b)(6). I removed helmet d/t concerns of continued problems with being able to open right eye. On monday (b)(6), i called another orthotic company to confirm the info that i was being told was correct and she agreed to evaluate him. She rescanned his head and checked to make sure proper fitting of helmet was being achieved. I was informed at this time that the timeframe, mandated by fda, from scanning to new helmet replacement is 14 days. By checking the dates above, you will see that my son went 6 weeks and 2 days from scan to helmet placement. Thankfully my son did not have any ill effects as a result of this, but i am concerned that someone will not have this luck and may cause serious adverse reactions as a result of this.
Patient Sequence No: 1, Text Type: D, B5