(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 upper buttocks on (b)(6) 2016.Reaction was described as an abscess on the buttocks area.On (b)(6) 2016, the patient was given antibiotics by their doctor to treat the abscess.At the time of contact, the patient was healthy.No additional event or patient information is available.No product or data was returned for evaluation.The reported event of skin reaction could not confirmed.A root cause could not be determined.
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