Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Perforation (2001)
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Event Date 08/04/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly presenting with tympanic membrane perforation and cholesteatoma.The recipient is presenting with device extrusion.Revision surgery will be scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient was prescribed a seven day course of amoxicillin on (b)(6) 2020.The recipient is healing well and there are no concerns regarding an infection.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Manufacturer Narrative
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The recipient's cholesteatoma was surgically removed.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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