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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
Itching Sensation (1943); Scarring (2061); Burning Sensation (2146); Reaction (2414)
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Event Date 01/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).The g5 system is associated with product code pqf.
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Event Description
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Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced a skin reaction.Date of issue is an approximation.Sensor was inserted into the abdomen on (b)(6) 2017.Patient stated that they developed burning and an itching sensation approximately 2-3 days after sensor insertion and after day 7, scarring developed.Reaction extended outside the area where the sensor patch was adhered to the skin.The affected area was treated with over-the-counter neosporin.Dexcom made further contact with the patient on 04/27/2017.The patient reported that she has been using dexcom for approximately 1 year and after 6 months of sensor placement, began to experience redness and itching, which would begin on about day 3 of sensor wear.After sensor removal, the skin would often appear raw and exposed.Patient reported that subsequent dexcom applications skin irritation increased in intensity and the onset of symptoms would occur within one day of sensor insertion.The patient has used over-the-counter neosporin to treat the reactions and had not seen a physician.The patient has also tried tegaderm and tough pads as skin barriers, with only a limited decrease in itching and burning.Patient indicated that they stopped using the dexcom system for an unspecified time.At the time of contact, the patient was in good condition.No additional event or patient information is available.
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Search Alerts/Recalls
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