MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR ADHESIVE; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Rash (2033)

Event Date 03/25/2020

Event Type  Injury  

Event Description

Caller stated the adhesive that sticks the sensor to her daughter's skin formed a rash causing irritation, erythema (lasting 2 weeks after removal), and itching.Caller changes sensor every 10 days as indicated.Caller reported device concerns to manufacturer.Manufacturer stated they haven't changed the adhesive formula and are unaware of the cause of the reaction.

• Brand Name: DEXCOM G6 SENSOR ADHESIVE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10009272
• MDR Text Key: 189495377
• Report Number: MW5094310
• Device Sequence Number: 3
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/28/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11 YR