(b)(4).The user's guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).
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Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient experienced a skin reaction at the sensor insertion site.The sensor was inserted on (b)(6) 2017 at the abdomen.The reaction was described as redness and swelling.Affected area was treated with triamcinolone 0.1% usp.Date of prescription is unknown.At time of contact, patient is okay.No additional patient or event information was provided.No product or data were provided for evaluation.The reported event could not be confirmed.A root cause could not be determined.
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