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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
Burns by adhesive changes; i use the dexcom g6 sensors as i am a type 1 diabetic and they are absolutely necessary for my blood sugar management. The original adhesive from 2018 to march 2020 worked fine. They changed the formula in (b)(6) 2020 and since then until now, i am 10s of thousands of other type 1 diabetics get horrid skin burns and contact burns that require steroids and advanced treatment. It is not right, and they refuse to fix the problem and take advantage of my autoimmune disease for profit. 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 Key14430039
MDR Text Key292039817
Report NumberMW5109762
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 05/17/2022 Patient Sequence Number: 1
Treatment
NOVOLOG INSULIN
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