• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Tissue Breakdown (2681); Reaction to Medicinal Component of Device (4574)
Event Date 01/19/2021
Event Type  Injury  
Event Description
Dexcom g6 changed their sensor adhesive causing severe skin reactions. The adhesive is eating my skin causing major itching, a rash and layers of skin to be ate away. The oozing from the reaction causes the g6 sensor to fall off after about 5 days (should be able to wear for 10 days). I have called dexcom several times within the past year but nothing is done to change the adhesive. There are several reports of people having the same problem online. This problem has been online for the past year. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11214200
MDR Text Key228440319
Report NumberMW5098946
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 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 01/21/2021 Patient Sequence Number: 1
-
-