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

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

Patient Problems Itching Sensation (1943); Scarring (2061); Skin Irritation (2076)

Event Date 10/22/2020

Event Type  Injury  

Event Description

Complete allergic reaction to the adhesive dexcom now uses for their g6 sensors. Damaged skin, terrible itchiness. Scarred for weeks. Fda safety report id # (b)(4).

• Brand Name: DEXCOM CGM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10733253
• Report Number: MW5097439
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

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

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

• Patient Outcome(s): Other