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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number ANY MFD AFTER 12/2019
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Discharge (2225); Reaction (2414)
Event Date 04/01/2020
Event Type  malfunction  
Event Description
Since dexcom changed the adhesive on their g6 sensors. I, like many people on (b)(6) group, have a very bad reaction skin reaction. After 10 days of use when removing, the skin underneath is burned, scaly and oozy, and takes weeks or longer to heal. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11272555
MDR Text Key230315248
Report NumberMW5099167
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 01/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberANY MFD AFTER 12/2019
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

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