Model Number CI-1601-05 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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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Event Description
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The recipient is reportedly experiencing retention issues.Skin flap thinning surgery has been scheduled.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction information: section h.6.Advanced bionics considers the investigation into this reportable event as closed.The recipient will reportedly not pursue skin flap revision surgery at this time.Retention issues have resolved.It is believed retention issues improved with swelling reduction.No further 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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