At the time of this report, no further patient injury or negative health related outcomes have been reported.Entellus medical will continue to monitor this situation and provide subsequent reports if required.The device was discarded after the procedure.However, the device history records were reviewed.All manufacturing and quality assurance testing was carried out in accordance with standard procedure, and the device met specification at the time of release.(b)(4).
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It was reported that after a right frontal balloon dilation with an xpress balloon device and followed by a full fess of the frontal, sphenoid, maxillary and ethmoid sinuses with septoplasty and bilateral turbinate reduction a csf leak was noticed near the left frontal sinus.The csf leak was repaired with a patch using skin graft along with packing product.The patient was admitted overnight for observation and discharged home the following morning without further issues.No further patient injury or complications have been reported.
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