MAUDE Adverse Event Report: WAL-MART STORES, INC. EQUATE ANTIBACTERIAL BANDAGES; TAPE AND BANDAGE, ADHESIVE

Device Problem Chemical Problem (2893)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Email complaint from (b)(6) on the chemical burn her daughter received from the walmart (equate brand) antibacterial bandages.Following is mother's email "my name is (b)(6), on wednesday (b)(6) 2023 my daughter was playing outside and fell which resulted in a scrap on her thigh.I then cleaned the wound with water and placed an antibacterial bandage from walmart (equate brand).After replacing it i noticed my daughter being sensitive to the touch, but thought it was just from her fall.Saturday i noticed her bandage leaking, thinking it was blood i removed the bandage (which wasn't blood) and replaced it with another one.Sunday (b)(6) 2023 my daughter pointed out that her leg was leaking again and was in a lot of pain.When i removed the bandage i noticed a huge chemical burn on her thigh the size of the padding from the bandage.As soon i noticed this i took a picture and immediately looked up the box on the walmart website to check the ingredients.I also looked up reviews and noticed several people mentioning they have all gotten chemical burns from these bandages.(the first review being from 2019 to the last one in 2021.) being that it was after hours i was unable to call the number on the box until the next day (b)(6) 2023 which i did and spoke with (b)(4) who mentioned all she could do it send a message to the supplier.I also took my daughter to her pediatrician who confirmed it was not a allergic reaction and a burn.Mind you the ingredients are "benzalkonium chloride (0.8%) which is way over the safe level of 0.1%.The brand bandaid and other bandaids with this chemical only contain 0.1% (the doctor also said that chemical shouldn't be on a bandaid with that amount of concentration) this product needs to be recalled or removed from the shelf, as of today when looking at the walmart website 500+ boxes have been sold in the last 24 hours.Please help me get this product recalled or off the shelves before someone else gets hurt.Thank you for your time, (b)(6).

• Brand Name: EQUATE ANTIBACTERIAL BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WAL-MART STORES, INC.
• MDR Report Key: 16790742
• MDR Text Key: 313842089
• Report Number: MW5116904
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BENZALKONIUM CHLORIDE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female