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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Superficial (First Degree) Burn (2685)

Event Date 03/01/2021

Event Type  Injury  

Event Description

I wear dexcom 6 sensor and after a couple days on my stomach it starts to itch pretty bad.By the time 10 days are up, when it's time to change the adhesive has pretty much burned a circle the size of the patch that is completely red and raw.Kinda like an open wound.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11495305
• MDR Text Key: 240404408
• Report Number: MW5100008
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Model Number: G6
• Device Catalogue Number: STS OM 003
• Device Lot Number: 5281851
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 86