(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 08/24/2016, that on (b)(6) 2016, the patient experienced bleeding.The sensor was inserted on (b)(6) 2016.The patient inserted a new sensor into abdomen and the sensor patch filled with blood.The patient then removed the sensor and inserted a new sensor into the other side of his abdominal area.The patient applied a band-aid on the previous insertion site and went to bed around 11:00pm.The patient woke up around 4:00am and the old insertion site was filled with blood.The patient applied pressure and ice to the area with gauze.The area filled with blood again and it was replaced with more gauze.Patient's wife drove the patient to the emergency room (er) and they arrived at 4:30am.The patient was treated with gauze, additional pressure and wound sealer powder that stopped the bleeding.The patient was at the er until 7:00am.At the time of contact, the patient was well and at home.No additional event or patient information was provided.No product or data was returned for investigation.The reported event could not be confirmed.A root cause could not be determined.
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