(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 (b)(6) 2016, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2016.The patient described the reaction as red with bleeding and liquid discharge.Reaction was in the shape of the adhesive patch and was located on the belly.On (b)(6) 2016, the patient's father called and spoke with an endocrinologist regarding the reaction, who advised that they treat the patient with over-the-counter hydrocortisone cream.The affected area was treated with neosporin.At the time of contact, the patient was okay.Additional event or patient information is not available.No product or data was provided for evaluation.The reported skin reaction was not confirmed.A root cause could not be determined.
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