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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 10/02/2020

Event Type  Injury  

Event Description

Chemical burn; placed dexcom g6 lasted the whole time removed device have a chemical burn the size of the device.Went to dr have highest prescribed steroid ointment.Cannot take pill steroids.This is not the first time this has happened it's been happening since january; super angry from the burns to the scars.Product is great but why change adhesive if it was working good the first time? fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10642020
• MDR Text Key: 210401087
• Report Number: MW5097117
• Device Sequence Number: 1
• Product Code: MDS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 87