Model Number AB-5100H-11A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Head Injury (1879); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's swelling has resolved.The recipient is using the device.No further treatment 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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Event Description
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The recipient reportedly experienced swelling at the implant site after a head trauma.The recipient was prescribed antibiotics (type unknown).
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.A biopsy of the head wound was completed (b)(6) 2024.The recipient's wound from the head injury was reportedly not device related.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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