Model Number CI532 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on december 30, 2019.
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Event Description
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Per the clinic, the patient experienced an infection of the outer ear which was treated with antibiotics (unknown type).The device was explanted (b)(6) 2019.It is unknown if the patient has been re-implanted with another device.
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Manufacturer Narrative
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Correction: the device was not explanted as previously reported.The patient underwent skin revision surgery, the device remains in-situ.This report is submitted on 6 april 2020.
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Search Alerts/Recalls
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