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

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

Patient Problems Skin Erosion (2075); Skin Irritation (2076)

Event Date 10/25/2020

Event Type  Injury  

Event Description

This is about dexcom's g6 continuous glucose monitor.The adhesive has been changed recently, and the new adhesive is incredibly irritating.It never happened prior to (b)(6) of 2020 this isn't a "sensitive skin" issue; see the attached two pictures, both of these were after the sensor was on for 3 days (supposed to last for 10).It actually ate away a layer of skin, and this has happened each and every time i've used this product for the last year or so, and i'm running out of places on my body to use this.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10748280
• MDR Text Key: 213689568
• Report Number: MW5097497
• Device Sequence Number: 3
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/25/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 84