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U.S. Department of Health and Human Services

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

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DEXCOM, INC. G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Contamination (1120)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Swelling (2091); Tissue Damage (2104); Burning Sensation (2146); Reaction (2414)
Event Date 02/18/2020
Event Type  Injury  
Event Description
I have been on the dexcom for over 10 years. The last sensor i wore started itching really bad on day 5 of wear. I continued to wear for the entire 10 day period. Around day 8 my skin under the adhesive started oozing. I attached a picture. When i removed it, my skin was burning and very painful. It was bright red and had tiny bumps all over. I put hydrocortisone on it. About a day later, my skin started peeling similar to a sun burn and felt extremely dry. I have been ¿along¿ lotion daily and it is still dry and itchy and red. My current sensor is also doing the same thing. Itchy and residue around the edges. I know this has to be a change in the adhesive because i¿ve never had a reaction like this before or had this nasty residue in all the years using. Do you have a picture of this product? yes. Fda safety report id # (b)(4).
 
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Brand NameG6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key9775066
MDR Text Key181771814
Report NumberMW5093421
Device Sequence Number2
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 02/26/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/28/2020
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
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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