MAUDE Adverse Event Report: KENVUE BRANDS LLC/ JOHNSON & JOHNSON BAND-AID WATERPROOF; TAPE AND BANDAGE, ADHESIVE

Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I used a johnson & johnson waterproof band-aid to cover some lesions on my stomach and hip.They say they are made without natural rubber latex.I am allergic to latex and read labels carefully.A few minutes after applying the bandages i started itching and thought it was just dry skin.Soon after i felt my skin burning and looked at the areas covered in band-aids.The area was swollen and red, burning and itching.I removed the bandages and now have large red mounds with peeling skin where the adhesive was.

• Brand Name: BAND-AID WATERPROOF
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): KENVUE BRANDS LLC/ JOHNSON & JOHNSON
• MDR Report Key: 23780673
• Report Number: MW5180374
• Device Sequence Number: 13372668
• Product Code: KGX
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/07/2025

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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATORVASTATIN 10 MG; LEVOTHYROXINE; LOSARTAN 25 MG; METFORMIN 1000 MG
• Patient Sex: Female
• Patient Weight: 150 KG
• Patient Race: White