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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENDOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Blister (4537)
Event Date 07/01/2022
Event Type  Injury  
Event Description
Have had serious reactions to the adhesive on the dexcom g6 sensors. Have used the product for over six months without issue. The past two month each time using the product i have severe itching while wearing it, when the product it removed i have severe redness and blisters on my skin. It takes over a week for the redness to go down. It's my understanding that the company recently changed the adhesive in the product. The company will product a new sensor when you contact them but i feel the company need to address the issue at once. As a consumer i feel this is a medical device, and it's not acceptable to accept to go through this just to use the device. Thank you (b)(6). Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENDOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key15067169
MDR Text Key296324708
Report NumberMW5110984
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
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: 07/19/2022 Patient Sequence Number: 1
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