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MAUDE database and Eustachian tube balloon dilation: Evaluation of adverse events and sales data.

Zaid ShareefRobert M ConwayTrevor CreamanSeilesh C Babu
Published in: American journal of otolaryngology (2024)
ETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.
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