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

Model Number G6

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

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

Event Date 06/10/2020

Event Type  Injury  

Event Description

Irritation, burn; adhesive caused skin reaction, itchiness, scarring.Fda safety report id# (b)(4).

• Brand Name: G6 TRANSMITTER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10493734
• MDR Text Key: 205906199
• Report Number: MW5096426
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 64