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Model Number 9500-27 |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Itching Sensation (1943); Swelling (2091); Reaction (2414)
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Event Date 01/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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Dexcom was made aware on 10/12/2016, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the upper buttocks on (b)(6) 2016.The reaction was described as itchy, red welts and swelling underneath the sensor adhesive.On (b)(6) 2016, the patient went to a regular dermatology appointment and while there, consulted with the dermatologist about the skin reaction.The dermatologist stated that the reaction looked like a contact irritation and the doctor did not have any recommendations or give a prescription.Patient was advised that they could use the prescription they already had, which was topicort.The affected was treated with the prescription topicort.At the time of contact, the patient was well.Additional event or patient information is not available.No product or data was provided for evaluation.The reported event of skin reaction was not confirmed.A root cause could not be determined.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.
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Search Alerts/Recalls
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