Internal complaint reference: (b)(4).Aukema, t.W., edens, m.A., & rinia, a.B.(2021).Office based inferior turbinate coblation treatment: a randomized controlled trial on effectiveness and tolerability of medicinal honey.Doi: (b)(6).
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H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A clinical review states the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patients impact beyond the reported cannot be determined and the patient¿s current health status is unknown.Therefore, no further clinical/medical assessment can be rendered.Should any additional clinical information be provided, this complaint may be re-evaluated.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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