MAUDE Adverse Event Report: 3M COMPANY TEGADERM; DRESSING, WOUND, DRUG

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

Patient Problems Rash (2033); Blister (4537)

Event Date 11/01/2020

Event Type  Injury  

Event Description

My son has been using the dexcom cgm, g5 and now g6, for the last 2 plus years without any adverse side effects.Starting in november he started to develop very bad rashes with some blistering that required treatment with antibiotic cream.I made contact with dexcom and was advised that they had changed a binding agent in the adhesive and they provided me different things to try.We first tried skintac, barrier wipe.This did not work and the rash continued.We then tried tegaderm, barrier film.That also did not help with the rash.I spoke to dexcom again and they recommended that we try spraying flonase on the skin first and if that didn't work, we should use a thicker barrier film, duoderm.My son tried flonase alone and that did not help the rash.Finally, he is now trying the duoderm product.As a type 1 diabetic my son needs his cgm to appropriately monitor his blood sugar and the lows that can be life threatening.We are looking for assistance as he had no problem prior to the change by dexcom in their adhesive formula.Fda safety report id # (b)(4).

• Brand Name: TEGADERM
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 11272783
• MDR Text Key: 230532964
• Report Number: MW5099181
• Device Sequence Number: 3
• Product Code: FRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• 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?: Yes
• 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: 21 YR
• Patient Weight: 98