Model Number CI512 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Erosion (2075)
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Event Date 06/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on june 26, 2020.
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Event Description
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Per the clinic, the patient experienced skin breakdown at implant site.Subsequently the patient underwent a surgical procedure on (b)(6) 2020 to repair the skin flap.The implanted device remains.
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Event Description
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It is reported that the device was explanted on (b)(6) 2020.
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Manufacturer Narrative
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It was reported that the patient's device had extruded.Explant and re-implantation is planned but has not taken place as of the date of this report.This report is submitted 03 september 2020.
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Event Description
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It was reported that the patient's device had extruded.Explant and re-implantation is planned but has not taken place as of the date of this report.
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Search Alerts/Recalls
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