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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 7292536
Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)
Patient Problems Erythema (1840); Itching Sensation (1943); Scar Tissue (2060); Caustic/Chemical Burns (2549)
Event Date 08/28/2021
Event Type  Injury  
Event Description
Adhesive chemical burn; extreme red chemical burn and intense itching within two days applying the dexcom g6 sensor. Have used several more sensors and had the same issue. Up until (b)(6) 2021 i had no issues with the same sensors. I presume something with the chemical makeup of the adhesive has changed and has become toxic. I have uploaded pictures that i can share of the burns. These burns take several weeks to heal, are leaving rough and scarred skin where the adhesive burn effected the skin. 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 Key12546793
MDR Text Key274013584
Report NumberMW5104250
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 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7292536
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: 09/28/2021 Patient Sequence Number: 1
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