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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
Lot Number 5271049
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); Caustic/Chemical Burns (2549)
Event Date 07/17/2020
Event Type  Injury  
Event Description
Dexcom has recently switched their adhesive on the g6 sensors, which has left me with severe skin irritation. I have been using the g6 for well over a year now, and never had a problem until they switched the formula. It's like a red chemical burn that's left on my skin that remains itchy for multiple days after it has been removed. 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 Key10326326
MDR Text Key200685478
Report NumberMW5095729
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2021
Device Lot Number5271049
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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