Envoy medical corp.(emc) was notified on 09/16/2022 of a patient that experienced skin breakdown in the surgical incision region and signs of infection (redness, draining).The patient last had a battery change (b)(6) 2021.The reporting surgeon noted that the issue may be related to scuba equipment abrading the skin in the incision area and eye glasses further exacerbating the issue.The patient was fully explanted (b)(6) 2022.Patient/clinical history with emc: 2013 (b)(6), implant, 2014 (b)(6), fitting, 2014 (b)(6), fitting, 2014 (b)(6), revision, 2014 (b)(6), fitting, 2014 (b)(6), fitting, 2015 (b)(6), fitting, 2021 (b)(6), battery change, 2021 (b)(6), fitting, 2022 (b)(6), explant.
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