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

Lot Number 5290536

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 10/06/2021

Event Type  Injury  

Event Description

Severe itching and rash; had severe itching 4 days after attaching dexcom g6 sensor.Once i removed the sensor at the end of the 10 day use period, i found a rash/hives under the sensor which do not appear to be clearing up.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 12633321
• MDR Text Key: 276841980
• Report Number: MW5104605
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 5290536
• 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: 34 YR
• Patient Weight: 73