Model Number CI24RE (ST) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
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Event Date 04/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on april 28, 2020.
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Event Description
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Per the clinic, the patient experienced an infection with recurrent discharge and pus from his ear which was treated with oral antibiotics.The device was explanted on (b)(6) 2020.The infection is unresolved.Clinical management is ongoing.
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Manufacturer Narrative
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Per the clinic, prior to the explant, there was a skin flap revision surgery (date unknown).This report is submitted on (b)(6) 2020.
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Manufacturer Narrative
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The device analysis report is attached.This report is submitted on november 20, 2020.
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Search Alerts/Recalls
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