Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Pain (1994)
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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 pain and redness at the implant site.The recipient was prescribed antibiotics.
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Manufacturer Narrative
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Additional information: section d.6b.Advanced bionics considers the investigation into this reportable event as closed.The recipient's issues have reportedly resolved.The recipient continues to use the device.No further treatment details will be provided.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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