(b)(4).The dexcom g5 mobile 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).
|
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a rash on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.Rash was described as itchy and containing pus.Rash was located under the adhesive area.On (b)(6) 2016, the patient was taken to the urgent care with a low-grade fever of 99.5.It was further reported that the patient was taking an oral anti-biotic and insulin.Rash was treated with an anti-fungal and bacterial cream.At the time of contact, the patient was feeling better at the affected site.Additional event or patient information was not provided.
|