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

Lot Number 7292536

Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)

Patient Problems Erythema (1840); Itching Sensation (1943); Scar Tissue (2060); Caustic/Chemical Burns (2549)

Event Date 08/28/2021

Event Type  Injury  

Event Description

Adhesive chemical burn; extreme red chemical burn and intense itching within two days applying the dexcom g6 sensor.Have used several more sensors and had the same issue.Up until (b)(6) 2021 i had no issues with the same sensors.I presume something with the chemical makeup of the adhesive has changed and has become toxic.I have uploaded pictures that i can share of the burns.These burns take several weeks to heal, are leaving rough and scarred skin where the adhesive burn effected the skin.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12546793
• MDR Text Key: 274013584
• Report Number: MW5104250
• 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
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Lot Number: 7292536
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 66