Model Number CI24RE (S8) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Date 12/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on january 11, 2021.
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Event Description
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Per the clinic, the patient experienced skin irritation at the implant site.The device was explanted on (b)(6) 2020.There are no plans to reimplant the patient with a new device as of the date of this report.
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Manufacturer Narrative
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It was reported that prior to explant the patient experienced infection at implant site.This report is submitted on 19 january 2021.
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Manufacturer Narrative
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This report is submitted february 12, 2021.
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Search Alerts/Recalls
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