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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 01/02/2023

Event Type  Injury  

Event Description

Dexcom g6 reaction to the tape.This leaves a terrible rash, burn mark on my daughter every time she uses one.

• Brand Name: DEXCOM G6 ADHESIVE PATCH
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 16132190
• MDR Text Key: 307081091
• Report Number: MW5114243
• Device Sequence Number: 1
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DEXCOM G6; INSULIN ; INSULIN PUMP
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White