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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Caustic/Chemical Burns (2549)
Event Date 10/12/2020
Event Type  Injury  
Event Description
Skin burn; extreme skin irritation/chemical burn from dexcom g6 glucose monitor. I was supposed to leave on for 10 days but had to remove after 7 because of extreme irritation. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 GLUCOSE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10684433
MDR Text Key211714017
Report NumberMW5097243
Device Sequence Number1
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/08/2021
Device Model NumberG6
Device Catalogue Number9500-45
Device Lot Number7277593
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: 10/14/2020 Patient Sequence Number: 1
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