Pain at insertion site is a known and anticipated potential adverse effect, which does not require additional investigation per (b)(4).Since user wanted to have the sensor removed, the user was advised to contact the inserting hcp to make an appointment for removal.She was also advised to contact the insurance directly to discuss about the coverage for the procedure.Further follow up regarding sensor removal was not possible due to lack of response from the user.
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On (b)(6) 2022,senseonics was made aware of an adverse event where user has a lot of pain on the surface of the arm where the sensor was inserted.User feels pain every time the transmitter is put on,taken off or even the surface is touched.User wanted to have the sensor removed, the user was advised to contact the inserting health care professional to make an appointment for removal.
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