MAUDE Adverse Event Report: UNKNOWN ANTIBACTERIAL ADHESIVE PADS; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/01/2023

Event Type  Injury  

Event Description

I purchased walgreens brand antibacterial adhesive bandages to treat a small open wound on my leg.I used the product for two days before determining the issue was the benzalkonium chloride mix that was acting as the antibacterial.After further research, it appears that this compound is known to cause irritation to skin and is shocking that it is used to treat open wounds.Apparently equate and a few other companies are using this as well.There are countless complaints online about the substance causing chemical burns, please remove these products from the shelves.

• Brand Name: ANTIBACTERIAL ADHESIVE PADS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16888640
• MDR Text Key: 314884957
• Report Number: MW5117369
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• 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: 05/02/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male