Model Number 102096-81A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Discomfort (2330)
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Event Date 11/06/2023 |
Event Type
Injury
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Event Description
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On november 6, 2023, senseonics was made aware of an adverse event where the user reported a failed removal attempt.
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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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Manufacturer Narrative
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The sensor was successful removed on the second removal attempt on (b)(6) 2024.No further investigation is required.B4.Date of this report (b)(6) 2024.D4.Primary unique device identifier (udi) number updated to (b)(4).D6b.Explanted date updated to (b)(6) 2024.G3.Date received by the manufacturer? 02 july 2024.
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Search Alerts/Recalls
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