(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).The g5 system is associated with product code pqf.
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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 abdomen.The sensor was inserted at the abdomen on (b)(6) 2017.The reaction was described as itching and bruising.Patient spoke to a physician who advised the patient to monitor it.No medication was recommended.At the time of contact, patient is good.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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