Model Number CI-1600-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Swelling (2091)
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Event Date 01/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient resumed device use.This is the final report.
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Event Description
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The recipient reportedly experienced otitis media and early mastoiditis.The recipient presented with redness and swelling at the implant site.The recipient ceased devise use.An ear ventilation tube was placed and 48 hour hospitalization with iv antibiotics was initiated.The recipient's issue resolved with antibiotic treatment.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed 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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