Review of the manufacturing records confirmed that the device was manufactured to specification.Review of the provision of treatment confirmed that all standard clinical procedures were followed.Parents had routine questions throughout treatment, with these questions/concerns being addressed at each visit.The device does appear to have been taken off more frequently than advised.No one witnessed the event that led to the injury and the timeline of the injury is uncertain, so no determination has been made at this point as to whether, or what role, the device played in the reported injury.The investigation is ongoing.
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Healthy patient (minor) was in treatment with cranial orthosis for 3 months.During the treatment period, baby suffered an injury to the nose causing a blood clot (septal hematoma) requiring surgery.Mom disclosed during the next appointment that baby had surgery to address the injury on (b)(6) 2020.During this appointment, an adjustment was made to the front of the band to keep it from irritating the surgical area.Patient had two weeks of treatment left at this point, but parents canceled the exit appointment.Almost 5 weeks later, parents scheduled and came in for an exit appointment on (b)(6) 2020.During this appointment, parents reported that the baby had broken his nose and had a septal hematoma (rather than what was initially reported as a blood clot).Though they (parents) did not see the injury occur, their ent felt that the band caused the injury.Since the injury/event was not observed, and no injury was externally noticeable or identified for several days, it is not clear exactly when the injury occurred.As a result, it is not clear at this point whether the cranial orthosis was involved in causing the injury.
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