(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).
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Dexcom was made aware on 08/08/2016 that the patient experienced a skin reaction on (b)(6) 2016.The sensor was inserted into the buttocks on (b)(6) 2016.Reaction was located around the white, sensor adhesive tape and was described as redness that turned into bumps and opened into sores.On (b)(6) 2016, patient's mother took the patient to the dermatologist for the skin reaction.Affected area was treated with triamcinolone cream prescribed by dermatologist.At the time of contact, the patient was still experiencing reaction to sensors.Additional event or patient information was not provided.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.
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