MAUDE Adverse Event Report: WALGREENS BOOTS ALLIANCE, INC. WALGREEN ANTI BACTERIAL PLASTIC BANDAGES; TAPE AND BANDAGE, ADHESIVE

Lot Number 00179043

Patient Problems Rash (2033); Blister (4537); Swelling/ Edema (4577)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

(b)(6) allergic reaction to bandage- walgreen anti bacterial plastic bandaid.The chemical name is benzalkonium chloride.Rash, broken, swelling and blisters.

• Brand Name: WALGREEN ANTI BACTERIAL PLASTIC BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WALGREENS BOOTS ALLIANCE, INC.
• MDR Report Key: 17374808
• MDR Text Key: 319719029
• Report Number: MW5119838
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 00179043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2023
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White