(b)(4).The dexcom g4 platinum continuous glucose monitoring system user's guide states: inserting the sensor and waring 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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Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a skin reaction to the adhesive on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.The reaction was located on the abdomen underneath the adhesive and was described as raised, very red, extremely itchy and harder feeling skin.Patient's mother treated the affected area with a prescription antibiotic cream obtained from a non dexcom related event.The date the prescription was obtained is unknown.No additional event or patient information was provided.
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