Model Number 102096-67A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Discomfort (2330)
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Event Date 09/01/2020 |
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 (b)(6) 2020,senseonics was made aware of an adverse event where physician was unable to remove the sesnor in the first attempt made.
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Manufacturer Narrative
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Despite multiple follow up attempts with the user the removal status of the sensor could not be confirmed.D2.Product code changed to qhj.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4311.
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Search Alerts/Recalls
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