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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Local Reaction (2035); Impaired Healing (2378)
Event Date 04/11/2021
Event Type  Injury  
Event Description
Dexcom g6 sensors are causing intense skin reaction and persistent rash. Because these sensor should only be used in certain parts of the body i've had to place sensors on my skin that is still healing from a previous rash. I've been using dexcom for many years and just recently they are causing this bad reaction. There are now (b)(6) groups dedicated to people having these adverse reactions. Dexcom customer support offers no explanation and cannot tell me how to resolve this issue. Please investigate if they've started using a new adhesive that is not as safe. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11663949
MDR Text Key245565376
Report NumberMW5100757
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 04/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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