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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE
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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5276779
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)
Event Date 08/25/2020
Event Type  Injury  
Event Description
Incredibly bad rash; i use the dexcom g6 and a couple of months ago i started getting red, raised bumpy dots that itch really bad and feel like they're burning. It has caused me to take off the sensor early the last 2 times i used them because it was so bad. The rash lasts a couple of weeks. I have read on (b)(6) that this is happening to a lot of dexcom g6 users and just recently started over the last few months, like me. I've used this product for 4 years and only recently started getting rashes. The (b)(6) posts state that dexcom recently changed the formula of the adhesive. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10477175
MDR Text Key205339387
Report NumberMW5096352
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 08/27/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5276779
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

Patient Treatment Data
Date Received: 08/31/2020 Patient Sequence Number: 1
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