Patient's mother contacted dexcom on (b)(6) 2015, to report a skin reaction from the sensor that occurred on (b)(6) 2015.Insertion site and date of insertion is unknown.Patient's mother described the skin reaction as red, raised, itchy and painful skin.Patient was seen by his physician on (b)(6) 2015 for skin irritation.Physician recommended that patient use skin tac.Patient's mother reported that they have not started using it yet.At the time of contact, patient's mother reported current condition of skin irritation as "ok".No additional event or patient information is available.It should be noted that the dexcom g4 platinum continuous glucose monitoring system users guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring, or skin discoloration).
|