(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 reported that they experienced burning, itching, pain and pus at the left side of the abdomen.The affected area was treated with hydrocortisone cream prescribed approximately (b)(6) 2016.Patient had experienced their first skin reaction to dexcom in (b)(6) 2015 and has a history of skin reactions to adhesives.At the time of contact, the patient was still having skin reactions.Additional event or patient information is not 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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