Model Number 102096-67A |
Device Problem
Material Separation (1562)
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Patient Problem
Discomfort (2330)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer is currently performing an investigation, and will provide the results with the supplemental report.
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Event Description
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On october 30th 2020,senseonics was made aware of an adverse event where sensor broken in half, and only one piece of the sensor was removed during the removal procedure.
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Manufacturer Narrative
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Both old and new sensors (all pieces) were retrieved from the user per the case update on (b)(6) 2021.No further investigation is required.D6b.Explanted date updated to (b)(6) 2021.
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Search Alerts/Recalls
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