Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Tissue Damage (2104)
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Event Date 01/22/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing a thick skin flap.The recipient underwent skin flap thinning surgery on (b)(6) 2020.
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Event Description
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The recipient is reportedly experiencing retention issues due to a thick skin flap.The recipient underwent skin flap thinning surgery on (b)(6) 2020.
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Manufacturer Narrative
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The recipient is continuing to experience retention issues.A second skin flap thinning surgery is scheduled.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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On (b)(6) 2020, the recipient reportedly underwent a second skin flap thinning surgery.The recipient's issues have resolved.The recipient is using the device.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.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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