Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930)
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Event Date 04/18/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing an open abscess on the incision site that was described as a hot sensation over the implant site on (b)(6) 2021.On (b)(6) 2021, the abscess was drained and the recipient started an antibiotic treatment.On (b)(6) 2021, the recipient presented with pus pouring from the abscess.The pus was sent for culture and was identified as (b)(6).On (b)(6) 2021, the recipient's device was explanted.The recipient is in the process of healing.The surgeon believes the recipient's issues are due the recipient's immunocompromised status and not directly related to the device.Reimplantation will be considered once healing is complete.
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Manufacturer Narrative
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The recipient's incision site has reportedly healed well.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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The recipient¿s device was reportedly discarded and will not return to advanced bionics for analysis.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.A review of the device history record was completed and no anomalies were noted. 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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