Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/06/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced retention issues.The recipient underwent a skin slap thinning procedure on (b)(6) 2021.Following surgery, the recipient presented with an abscess at the implant site.The abscess was drained and the recipient is in the process of healing.
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Manufacturer Narrative
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The recipient continues to experience retention issues.The recipient is reportedly receiving injections at the site to help thin skin.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The injection of kenalog reportedly resolved the recipient's issues.The recipient is doing well and resumed device use.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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