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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Erosion (2075); Skin Irritation (2076)
Event Date 10/25/2020
Event Type  Injury  
Event Description
This is about dexcom's g6 continuous glucose monitor. The adhesive has been changed recently, and the new adhesive is incredibly irritating. It never happened prior to (b)(6) of 2020 this isn't a "sensitive skin" issue; see the attached two pictures, both of these were after the sensor was on for 3 days (supposed to last for 10). It actually ate away a layer of skin, and this has happened each and every time i've used this product for the last year or so, and i'm running out of places on my body to use this. Fda safety report id# (b)(4).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10748280
MDR Text Key213689568
Report NumberMW5097497
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 10/25/2020
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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