(b)(4).The dexcom g4 platinum 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 09/07/2016 that on (b)(6) 2014, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2014.The skin reaction was described as red, irritated, raw, itchy and burning.Patient stated that sometimes the skin would be open.Reaction was located under the adhesive.In (b)(6) of 2014, the patient spoke to her doctor about the skin reaction and was prescribed triamcinolone cream.Exact date of doctor visit was unknown.Patient stated that the reaction has been ongoing and has tried the following treatments over time: prescription triamcinolone cream, iv preparation pads, spray, no-sting barrier film, durable barrier cream, protective barrier film wipes and a preparation wash.No additional event or patient information is available.No product or data was returned for evaluation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.
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