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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G 6 SENSORS SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G 6 SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 7269747
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); Reaction (2414)
Event Date 07/03/2020
Event Type  Injury  
Event Description
Skin infection/irritation; i have use dexcom g6 sensors for over 3 years. In the past 2 months i have had a horrible skin reaction to the sensors which i have never had prior. I believe they have changed the adhesive and it is causing very serious skin reactions. After about 2 days of the sensor being applied my skin starts itching incessantly. I will notice a yellow crust substance appearing through the sensor adhesive bandage. By day 4, i am itching so badly that i have to pull part of the adhesive bandage back to allow the skin air to heal from the adhesive to the point the sensor is in jeopardy of falling off 6 days prior to the end date. My skin will be red/weeping, bumpy and the top layer is completely torn off from the adhesive. I have tried different skin barriers but i believe they have changed the adhesive without telling the consumers as i have heard of other consumer reports experiencing similar side effects. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G 6 SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10250261
MDR Text Key198382546
Report NumberMW5095436
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 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2021
Device Lot Number7269747
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: 07/08/2020 Patient Sequence Number: 1
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