Model Number CI-1500-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tinnitus (2103); Burning Sensation (2146)
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Event Type
Injury
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient is reportedly experiencing a burning sensation at the headpiece site with and without device use.The recipient is presenting with tinnitus and tenderness.The recipient was prescribed antibiotics and steroids.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.A ct scan revealed no anomalies.The recipient's issues resolved.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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Search Alerts/Recalls
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