Model Number 102812-81A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Discomfort (2330)
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Event Date 06/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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The next removal attempt is scheduled for some time after (b)(6) 2023, and the results of the removal attempt will be provided in the supplemental report.
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Event Description
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On (b)(6) 2023, senseonics was made aware of an adverse event where the physician was unable to remove the sensor from the user's arm on the first attempt due to not being able to remove it cleanly without causing tissue damage and contusion.
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Manufacturer Narrative
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Per case notes, the sensor was successfully removed and the user is doing well after the procedure.B4.Date of this report updated to (b)(6) 2023.G3.Date received by manufacturer updated to (b)(6) 2023.
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Search Alerts/Recalls
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