(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 08/20/2016 that the patient experienced a skin rash on (b)(6) 2016.The sensor was inserted on (b)(6) 2016.Date of issue and sensor insertion are approximations.On (b)(6) 2016, the patient went to the allergist and was prescribed bactroban 2% to be applied as needed.It was reported that the doctor believed that the irritation was a (b)(6) reaction.At the time of contact, the patient was stable.Additional event or patient information was not provided.No product or data was returned for investigation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.
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