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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 Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling (2091); Burning Sensation (2146)
Event Date 05/04/2020
Event Type  Injury  
Event Description
Severe chemical type rash; applied dexcom sensor, very soon after application the site became extremely itchy which i never experienced before. I took doses of benadryl throughout the 10 day wear session and applied antihistamine itch cream around the area. When i took the dexcom patch/sensor off my skin was left with red blisters, rash and almost appears to be scarred. Now that i have applied the next sensor i am having the same burning and severe itching sensations on another location in my body and am afraid my skin is also being harmed in the same manner. I have never had a problem with the dexcom device until recently so it appears as if something has changed to cause such drastic allergic type reactions. 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 Key10061145
MDR Text Key191252887
Report NumberMW5094503
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 05/13/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 05/14/2020 Patient Sequence Number: 1
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