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

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Tissue Damage (2104)

Event Date 08/01/2020

Event Type  Injury  

Event Description

I started to have serious skin reactions to my dexcom g6 sensors.While wearing the sensors, my skin gets incredibly itchy, and when i remove the sensor i have welts and seriously damaged skin that takes weeks to repair.Prior to august i had worn the dexcom sensors for six years with no adverse events.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10940044
• MDR Text Key: 219511010
• Report Number: MW5098177
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 70