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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Caustic/Chemical Burns (2549); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Event Date 04/10/2021
Event Type  malfunction  
Event Description
A dexcom sensor should last 10 days. I've have mine on for 7 days and it's been itching and burning. I couldn't take it anymore so i took it off today. I found my skin underneath the adhesive looked like a chemical burn - very red, flaky, blisters and irritated. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM GLUCOSE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11663938
MDR Text Key245576764
Report NumberMW5100756
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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