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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Event Date 08/07/2020
Event Type  Injury  
Event Description
Skin reaction; my son uses the dexcom g6 and has had an adverse reaction to the adhesive for about six months now. The device has a 10-day period where it is left on the skin. During these ten days, my son's skin becomes red and itchy where the adhesive is. When we remove the device on the tenth day, his skin is raw, inflamed, itchy, raised, bumpy, dry, and very red. Dexcom has to have changed their adhesive, since we've been using them proper without any problems. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10619562
MDR Text Key209819204
Report NumberMW5097032
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
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

Patient Treatment Data
Date Received: 10/01/2020 Patient Sequence Number: 1
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