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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 08/07/2020

Event Type  Injury  

Event Description

Skin reaction; my son uses the dexcom g6 and has had an adverse reaction to the adhesive for about six months now.The device has a 10-day period where it is left on the skin.During these ten days, my son's skin becomes red and itchy where the adhesive is.When we remove the device on the tenth day, his skin is raw, inflamed, itchy, raised, bumpy, dry, and very red.Dexcom has to have changed their adhesive, since we've been using them proper without any problems.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10619562
• MDR Text Key: 209819204
• Report Number: MW5097032
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 24