(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 07/21/2016 that the patient experienced cellulitis, located under the sensor patch, on (b)(6) 2016.The sensor was inserted into the arm on (b)(6) 2016.On (b)(6) 2016, patient was taken to the doctor and prescribed cefalexin.Affected area was treated with over-the-counter hydrocortisone cream and hydrogen peroxide water mixture and prescribed cefalexin.Site was also wrapped in gauze to keep clean and dry.At the time of contact, the patient had recovered okay.No additional event or patient information was provided.The sensor was inserted into the arm.Labeling indicates: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.No product or data was returned for evaluation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.
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