Model Number CI-1601-05 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problem
Ulcer (2274)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced an ulcer and device extrusion.The recipient's device was explanted.The recipient was not reimplanted.
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Manufacturer Narrative
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The recipient was reportedly prescribed antibiotics (type unknown) prophylactically.The recipient reportedly has very thin, atrophic scalp.The recipient is reportedly healing well.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 company was informed that the explanted device will not be returned to the company for analysis.A review of the device history record was completed and no anomalies were noted.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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