(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 (b)(4) 2016 that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2016.Skin reaction was described as being itchy and burning.Reaction was located at the insertion site.Patient stated that he has experienced skin reactions with the use of his last three sensors and has consulted with a nurse regarding the reactions.The affected area was treated with over-the-counter hydrogen and cortisone.Additionally, patient reported that the skin reactions take several weeks to heal and that the initial reaction had not fully healed yet.Patient indicated that he does not have a history of skin reactions or skin sensitivity.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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