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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Scarring (2061); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146); Impaired Healing (2378)

Event Date 05/25/2020

Event Type  Injury  

Event Description

Reporter said she has been experiencing burning, itching, high raised bumps, scarring, very red and warm skin from the sensor's adhesive.She also said it takes forever to heal.She said she did not have this problem using dexcom g6 sensors 5 months ago.She said she contacted the manufacturer for replacement since they don't last as long as they are supposed to.

• Brand Name: DEXCOM G6 SENSOR ADHESIVE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10514427
• MDR Text Key: 206555220
• Report Number: MW5096526
• Device Sequence Number: 5
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/09/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73