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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
Model Number G6
Device Problem Difficult to Remove (1528)
Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 01/31/2021
Event Type  Injury  
Event Description
Dexcom sensor tape has changed. It's like they're now using super glue. I've used dexcom for 8 years and have never had this issue until now. The glue is so strong, i have difficulty removing the tape at the end of 10 days. It takes a layer of skin off leaving welts and blood blisters after it's removed. I've never experienced this before. 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 Key11278711
MDR Text Key230477836
Report NumberMW5099210
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/10/2021
Device Model NumberG6
Device Lot Number7277598
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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