MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Caustic/Chemical Burns (2549)

Event Date 04/07/2021

Event Type  Injury  

Event Description

Dexcom g6 adhesive causing chemical burn and rash despite trying to use skin barriers underneath.Fda safety report id#: (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11640982
• MDR Text Key: 244878446
• Report Number: MW5100672
• Device Sequence Number: 1
• Product Code: QBJ
• 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: 04/07/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 31 YR
• Patient Weight: 66