MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM SENSOR ADHESIVE; TAPE AND BANDAGE, ADHESIVE

Device Problem Use of Device Problem (1670)

Patient Problems Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549)

Event Date 08/15/2023

Event Type  Injury  

Event Description

I had a severe chemical burn from the adhesive, and now cannot use any adhesives which is problematic as i wear cgms and a tandem t:slim insulin pump 24 hours out of every day.Also, since i have to do this i had to continue to use regular adhesives which eventually cause an allergic reaction all over my body.I finally discovered hydrocolloid bandages which are the only adhesives i can use now.Unfortunately they don't stick well but i'm also not allergic to them.I believe dexcom changed their adhesive formula.There is no way to easily report this information to them in their "support" forms so i'm unsure if they know the extent of this problem.

Event Description

Additional information received on 10/23/2023 for report #mw5147172.

• Brand Name: DEXCOM SENSOR ADHESIVE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 17975660
• MDR Text Key: 326295710
• Report Number: MW5147172
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2023
• Patient Sequence Number: 1
• Treatment: ACYCLOVIR 400 MG ; ACYCLOVIR 400 MG (2 IF HAVING A FLARE) ; BUPROPION XL 300 MG ; CELECOXIB 200 MG ; FISH OIL; FISH OIL 1200 MG ; FLUOXETINE 20 MG ; FLUOXETINE 40 MG ; HYDROXYZINE 25 MG; HYDROXYZINE 25 MG ; LEFLUNOMIDE 20 MG; LISINOPRIL 20 MG (AS OF AUG 2023) ; MORNING SULFASALAZINE 500 MG (2) ; SELENIUM; SELENIUM 200 MCG ; SIMVASTATIN 20 MG ; SULFASALAZINE 500 MG (2) ; VITAMIN C ; VITAMIN C 500-1,000 MG ; VITAMIN D; VITAMIN D3 5,000 IU (125 MCG) + K2 (100 MCG) ; VYVANSE 40 MG EVENING ; ZINC; ZINC 50 MG
• Patient Outcome(s): Other; Disability; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White