Model Number 102096-81A |
Device Problem
Material Separation (1562)
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Patient Problem
Discomfort (2330)
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Event Date 12/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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The next removal attempt has not been scheduled.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) 2023, senseonics was made aware of an adverse event where the sensor broke in half and the hcp was unable to remove one of the pieces from the user's arm.
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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.Since the user was not responsive no further investigation is required.B4.Date of this report 25 april 2024.G3.Date received by the manufacturer? 25 april 2024.
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Search Alerts/Recalls
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