(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 arm on (b)(6) 2016.Reaction was located around the white, sensor adhesive tape and was described as pink skin that becomes bumpy and turns into open sores.Affected area was treated with triamcinolone cream prescribed by patient's dermatologist for a previous reaction.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.The sensor was inserted into the arm.Labeling indicates: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.
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