Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
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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 swelling and inflammation at the incision site.The recipient was prescribed antibiotics (type unknown).The recipient is able to use device without pain.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.The recipient reportedly experienced a seroma which was aspirated with a needle and placed a mastoid dressing for 2 days.The recipient was prescribed 1 week of keflex.The recipient's issues resolved.The recipient 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.No additional information 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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