Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.The sensor was inserted by making a small incision and placing it under skin, and the potential for developing skin irritation/inflammation/infection at the insertion site is a known anticipated adverse event.The hcp was aware of the event and treated the user with generic loratadine and keflex, an antibiotic, for the insertion site.The incision has fully healed, and the user was advised to follow up with the hcp for further medical guidance.No further investigation is required.
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On (b)(6) 2023, senseonics was made aware of an adverse event where the user reported of noticing whipping, clear fluid coming from insertion site, swelling and feeling of heat on the area that was hard to the touch after three days of sensor insertion.
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