(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.Patient described the reaction as itchy, burning and with blisters.Reaction was located underneath the adhesive.The affected area was treated with over-the-counter hydrocortisone and pennsaid, prescribed by the patient's healthcare provider.Date of prescription was unknown.No additional event or patient information was provided.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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