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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Peeling (1999); Rash (2033); Reaction (2414); Caustic/Chemical Burns (2549); Skin Burning Sensation (4540)
Event Date 12/31/2020
Event Type  Injury  
Event Description
I was using my dexcom g6 for a couple months prior to the date listed. I had no reactions to my sensors/patch. A few times i had to get a replacement due to the sensor not releasing from its housing. When i used the replacements i had really bad skin reactions. Chemical burns, rashes, raised bumps, itchiness, peeled skin, dry, red and burning skin. I have always used skin tac because i already have sensitive skin. After getting my regularly supplied dexcoms throughout the next couple months i had these reactions. I tried using tegaderm with the skin tac as my doctor suggested. This helped make it through to the 10 day mark that the dexcom normally gets changed at. I was still having pretty bad reactions. I am now using layers of flonase and skin tac to keep the reactions to a minimum but they're still there. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11332443
MDR Text Key232220263
Report NumberMW5099391
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/10/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
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

Patient Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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