• 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
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Peeling (1999); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
Event Date 11/02/2021
Event Type  Injury  
Event Description
Severe skin irritation at sensor site. During the 10 day wear period the skin underneath the sensor grew itchy and hard to touch in some points. Upon removal skin was dark purple, peeled up a lot of skin causing bleeding. There was also yellow oozing puss and residue. The residue was also on the sensor patch when removed. In the following days site remained irritated, itchy, and bruised. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12787665
MDR Text Key280750362
Report NumberMW5105241
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 11/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Lot Number7291521
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/09/2021 Patient Sequence Number: 1
Treatment
DEXCOM G6 TANDEM T:SLIM X2 ; HUMALOG
-
-