Model Number 102096-81A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Discomfort (2330)
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Event Date 01/06/2024 |
Event Type
Injury
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Manufacturer Narrative
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This mdr is a result of retrospective review of complaints.According to the case notes, the area was palpable, and the transmitter was utilized to localize the area of the sensor but the sensor could not be removed.The next removal procedure is scheduled for (b)(6) 2024.
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Event Description
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On january 12, 2024, senseonics was made aware of an adverse event where the hcp could not remove the sensor from the user's arm on the first attempt.
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Manufacturer Narrative
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Sensor was successfully removed on (b)(6) 2024.No further investigation is required.B4.Date of this report 25 april 2024.D6b.Explanted date updated to (b)(6) 2024.G3.Date received by the manufacturer? 23 feb 2024.
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Search Alerts/Recalls
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