Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Hair Loss (1877); Itching Sensation (1943); Pain (1994); Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing skin irritation, inflammation and hair loss at the implant site.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient was prescribed a topical steroid cream.The recipient is presenting with pain, itchiness and redness.The recipient began using triamcinolone acetonide steroid ointment.
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Manufacturer Narrative
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The recipient is reportedly using the device as much as possible and the symptoms are improving, however, the recipient continues to experience retention issues.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's issues have reportedly resolved and healed.The recipient is using the device.Additional treatment details will not 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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