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Model Number 9500-27 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Abscess (1690); Erythema (1840); Reaction (2414)
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Event Date 04/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The user's guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).
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Event Description
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Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a skin reaction on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.Reaction was located at the abdomen.Patient's mother described the reaction as red, bumpy, hard, with pus.Affected area was treated with euromicron antibiotic ointment prescribed on (b)(6) 2015 for a previous reaction.At the time of contact, patient was doing well.No additional event or patient information was provided.
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Search Alerts/Recalls
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