Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; 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; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Pain (1994); Caustic/Chemical Burns (2549)
Event Date 03/15/2020
Event Type  Injury  
Event Description
We use the dexcom g6 continuous glucose monitor.In (b)(6) my son got the sensors in their new packaging.No big deal.The first sensor left mild irritation but came off early in his sleep.The second sensor he ripped off early because the irritation was more severe.The third sensor drove him crazy and hurt really bad but he managed to keep it on the full 10 days.When i took it off he had a severe chemical burn from the adhesive.While one dexcom, rep said they hadn't changed the adhesive formula, another said they had.(b)(6) i finally got them in the new packaging and i managed a whole 3 days before i took it off, it was painful.I have reported this to dexcom but can't get a clear response.We have been using this product for approximately a year and (b)(6) 2020 was the first time we had any issues.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G6 SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10167505
MDR Text Key195940543
Report NumberMW5095055
Device Sequence Number2
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/15/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/09/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age14 YR
Patient Weight41
-
-