MAUDE Adverse Event Report: CONVATEC, INC. DUODERM; DRESSING, WOUND, OCCLUSIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Scarring (2061); Skin Irritation (2076); Blister (4537); Contact Dermatitis (4546)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

I have been wearing a dexcom cgm for many years and have not had any issues with adhesive tape that hold the transmitter in place until now.My most recent box of sensors have caused an allergic dermatitis that has gotten worse every time i place a sensor.The last one i wore i had to take off after 4 day of use when they are supposed to last 10 days.My symptoms were very painful and included red blistered areas that were oozing pus when the sensor removed, were red and irritated for 2-3 days and eventually dried and then i had dry scaly areas of skin sloughing that were itchy.Eventually as these area were free from dry skin i have several areas of red "scar" areas.I contacted dexcom support line and they advised me that they have changed the adhesive used on their sensors and referred me to a website with several suggestions to put underneath their sensor to avoid the allergic reaction.I have tried duoderm, tegaderm, skin prep, placing dexcom's over patches underneath, hypafix tape and have still had allergic dermatitis no matter what i try.Their next recommendation was for me to contact my doctor.My doctor who is not a dermatologist referred me back to dexcom for solutions or offered to send me to a dermatologist.I am writing for help in getting these sensors changed to a tape that i am able to use to without terrible allergic dermatitis.I have had type 1 diabetes for 32 years and i believe that i should have access to the best equipment and/or supplies to manage my diabetes to prevent diabetes complications.With the use of a cgm i have been able to manage my diabetes and just want to be able to comfortably to use my dexcom g6 sensors.Fda safety report id # (b)(4).

• Brand Name: DUODERM
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): CONVATEC, INC.
• MDR Report Key: 11272981
• MDR Text Key: 230538086
• Report Number: MW5099182
• Device Sequence Number: 3
• Product Code: NAD
• 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: 01/31/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 70