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

Device Problem Product Quality Problem (1506)

Patient Problem Skin Irritation (2076)

Event Date 09/13/2020

Event Type  Injury  

Event Description

A caller stated that the dexcom sensor adhesive is burning his skin for the past two days.

• Brand Name: G6 DEXCOM SENSOR ADHESIVE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10541208
• MDR Text Key: 207381637
• Report Number: MW5096678
• 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: 09/15/2020
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage