MAUDE Adverse Event Report: 3M COMPANY NEXCARE WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Peeling (1999); Superficial (First Degree) Burn (2685); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Date 12/19/2023

Event Type  Injury  

Event Description

I had a burn on my arm from the corner of a hot pan.I covered it with a band-aid adhesive bandage overnight for 2 nights with no reaction.I wanted to use a bigger bandage, so i bought nexcare waterproof bandages on (b)(6) 2023 and applied one overnight.When i removed the bandage in the morning, the skin that was in contact with the adhesive was red and painful, and looked like i had a chemical burn.One side of the new wound also had little spots of blood and was oozing yellow fluid, and it appeared that the top layers of skin had come off along with the bandage.Over the next 6 days, most of the red skin turned hard and scaly, and it mostly peeled off on the 6th morning, but the side that was bleeding still shows deep tissue damage and is yellow in the middle where the skin is missing.I took photos of the wound.I have no known allergies.

• Brand Name: NEXCARE WATERPROOF BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 18411292
• MDR Text Key: 331639190
• Report Number: MW5149653
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/25/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2023
• Patient Sequence Number: 1
• Treatment: PRILOSEC
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Ethnicity: Non Hispanic