A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.The patient experienced swelling in the lips due to an allergic reaction.The patient visited the emergency room where the doctor prescribed antihistamine to alleviate the allergic reaction.The patient also consulted diabetic consultant who determined that the patient is allergic to oxybuprocaine because he had similar allergic reaction during an eye operation.Similarly, the patient could also be allergic to lidocaine which is used in insertion procedure.The patient is currently doing fine, and the allergic reaction has been reduced after taking antihistamine treatment.
|
On december 19, 2023, senseonics was made aware of an incident where the patient had an allergic reaction and went to the emergency room (er) because of swelling in the lip.Patient was inserted on (b)(6) 2023.Patient was prescribed with anithistamine which resolved the issue and is doing fine now.
|