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Catalog Number STS-OR-001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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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 (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)2021, that on (b)(6) 2021, the patient experienced a skin reaction. the sensor was inserted into the abdomen on (b)(6)2021.The patient stated itching, burning, rash, redness, inflammation, blisters, dry skin, and scar occurred.At the time of contact, it was indicated that the patient was stable.No additional event or patient information is available.
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Manufacturer Narrative
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(b)(4).H2- correction.H10- corrected data.3004753838 - 2021 - 86790 was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.
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Event Description
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Subsequent to the initial mdr, it was determined that a report was submitted in error.Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.
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Search Alerts/Recalls
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