Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn(s) (1757)
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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 reporting experiencing a burn area under the recipient's headpiece.The issues resolves when the headpiece is removed, however, recurs when sweating.The recipient was recommended to cease device use.
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Manufacturer Narrative
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Advanced bionics considers the this event to be non-reportable.The recipient reportedly did not experience a burn and no medical intervention was required.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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