Model Number CI522 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Discharge (2225)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on august 17, 2020.
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Event Description
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Per the clinic, the patient developed an infection and experienced pain and drainage at the implant site, due to recurrent cholesteatoma.The patient was treated with oral and topical antibiotics (duration and specific date not reported).Explant is planned but has not taken place at the time of this report.
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Manufacturer Narrative
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The device analysis report is attached.This report is submitted on november 13, 2020.
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Manufacturer Narrative
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It was reported that the device was explanted on (b)(6) 2020, re-implantation is planned but has not taken place as of the date of this report.This report is submitted on 15 september 2020.
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Search Alerts/Recalls
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