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U.S. Department of Health and Human Services

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

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DEXCOM, INC. G6 CONTINUOUS GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 9500-45
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Skin Irritation (2076)
Event Date 07/06/2020
Event Type  Injury  
Event Description
Skin irritation due to the adhesive on the dexcom g6 sensor. I am using a barrier, as i have been since i started using the system in (b)(6) 2019, but the last two boxes of product(3 pack) have been causing skin irritation after 1-2 days of wear. The sensors are supposed to be worn for 10 days so this causes significant discomfort. Fda safety report id# (b)(4).
 
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Brand NameG6 CONTINUOUS GLUCOSE MONITOR SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10332113
MDR Text Key200803979
Report NumberMW5095744
Device Sequence Number3
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 07/23/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-45
Device Lot Number5271496
Was Device Available for Evaluation? No Answer Provided
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: 07/27/2020 Patient Sequence Number: 1
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