(b)(4).The dexcom g4 platinum continuous glucose monitoring system user's guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G., redness, swelling, bruising, itching, scarring or skin discoloration).
|
Distributor contacted dexcom on (b)(6) 2016 to report on behalf of patient an allergic reaction that occurred on (b)(6) 2016.The sensor was inserted into the buttocks on (b)(6) 2016.Distributor states that when the reaction began it was just a rash, with itchiness and erythema.Patient also experienced pain and swelling and developed an imposthume that required the use of antibiotics.Patient had additional remedies used to reduce the swelling.Patient was seen by a doctor on (b)(6) 2016 regarding the irritation.After the second visit, the doctor advised that the patient stop using the continuous glucose monitoring device, as the allergic reaction was undoubtedly caused by the sensor patch adhesive.At the time of contact, the rash and the imposthume were slowly disappearing.No additional event or patient information was provided.
|