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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
Laceration(s) (1946); Reaction (2414)
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Event Date 06/30/2016 |
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 contacted dexcom on (b)(6) 2016 to report that the patient experienced a skin reaction on (b)(6) 2016.The location, date sensor was inserted, and description of the reaction are unknown.Patient reported using a "tape" skin barrier that, when removed, a part of her skin was also removed and created a wound.The name or type of tape is unknown.Patient reported that their healthcare provider didn't recommend any treatment.Date of healthcare provider contact is unknown.No additional event or patient information is available.
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Search Alerts/Recalls
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