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Model Number 9500-27 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rash (2033); Swelling (2091); Urticaria (2278); Reaction (2414)
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Event Date 06/01/2016 |
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 (b)(6) 2016, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2016.The skin reaction was described as a rash with red bumps, swelling and flaking.On (b)(6) 2016, the patient consulted their endocrinologist and was prescribed flonase, to be applied prior to sensor insertion.At the time of contact, the patient was in good condition.No additional event or patient information is available.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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Search Alerts/Recalls
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