Patient's mother contacted dexcom on (b)(6) 2016, to report that the patient experienced a skin reaction that occurred on (b)(6) 2016.Sensor was inserted at the arm on (b)(6) 2016.Patient's mother reported that the patient's skin was raw, irritated and bleeding.Patient's mother cleaned the affected area and applied prescription mupirocin.Patient's mother explained that mupirocin was prescribed for the patient's eczema and psoriasis.Additionally, patient's mother reported that she called the patient's nurse on (b)(6) 2016 and left a voice mail explaining the skin irritation and bleeding.No additional event or patient information is available.It should be noted that the dexcom g4 platinum continuous glucose monitoring system 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).Additionally, it was reported that the sensor was inserted at the arm.It should be noted that the dexcom g4 platinum continuous glucose monitoring system users guide states: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.
|