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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)
Patient Problems Purulent Discharge (1812); Erythema (1840); Nausea (1970); Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Event Date 06/11/2021
Event Type  Injury  
Event Description
In the past few months i have had an adverse reaction to the dexcom g6 sensor which i had used previously for 2 years with no issues. When contacting the company they admitted to changing the adhesive and a non-medical professional gave several tips for altering the device to help solve the problem such as adding a colloid bandage underneath this adhesive or a skin prep treatment. Each sensor leaves my skin with red, burn like reaction, raised bumps and scarred that last for over a 30 day period. This last sensor burned so bad after a few days it made me feel nauseous and i had to remove it. When i did it looked as if it had burned through several layers of skin as it was blistering and oozing pus. I facetimed my sister who is an rn with extensive er experience and she equated the reaction to the adhesive as heavy 2nd degree burn leaning toward 3rd degree burn and said that i needed to report it immediately. Fda safety report id#(b)(4).
 
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Brand NameSENSOR, GLUCOSE, INVASIVE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12086548
MDR Text Key260548713
Report NumberMW5102184
Device Sequence Number2
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 06/24/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/28/2021 Patient Sequence Number: 1
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