Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced swelling and presented with an air pocket at the implant site.A puncture procedure was performed.The recipient was advised to discontinue device use for one week.
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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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly healed and has resumed device use.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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