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U.S. Department of Health and Human Services

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

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DEXCOM INC DEXCOM G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Pain (1994); Scarring (2061); Reaction (2414); Caustic/Chemical Burns (2549)
Event Date 05/01/2020
Event Type  Injury  
Event Description
This is not an isolated event it is an ongoing issue. After placing on the cgm within hours you can feel the adhesive starting to burn the skin. These are chemical burns that leave scarring and are painful and itchy. Dexcom admits to changing their adhesive recipe but wont state exactly what they changed. They do not allow you to speak with their corporate office only their customer center. They make many suggestions all at the patient¿s expense instead of taking responsibility for their actions. I am not allergic to adhesive this is happening to thousands of dexcom patients who dexcom tells to find a way to deal with it. I am requesting that the fda step in and make dexcom correct this issue. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC
MDR Report Key11131782
MDR Text Key225809429
Report NumberMW5098719
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 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2021
Device Model NumberG6
Device Catalogue Number9500-45
Device Lot Number5279390
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: 01/06/2021 Patient Sequence Number: 1
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