Model Number 102096-67A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Discomfort (2330)
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Event Date 05/18/2021 |
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 may 21st 2021, senseonics was made aware of an adverse event where the physician was unable to remove the sensor on the first attempt made.
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Manufacturer Narrative
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Per case notes, the sensor was removed (b)(6) 2021.No further investigation was found necessary.D2.Product code updated to qhj.D6b.Explanted (b)(6) 2021.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4311.
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Search Alerts/Recalls
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