MAUDE Adverse Event Report: WALGREENS BOOTS ALLIANCE, INC. ANTIBACTERIAL FLEXIBLE FABRIC MEDIUM BANDAGES; TAPE AND BANDAGE, ADHESIVE

Device Problem Use of Device Problem (1670)

Patient Problem Contact Dermatitis (4546)

Event Date 04/21/2022

Event Type  Injury  

Event Description

Used (b)(6) brand antibacterial flexible fabric medium (2"x4") bandage with 0.8% benzalkonium chloride (bzk) (antiseptic) on (b)(6) male's cheek to treat abrasion.After 36 hours of wear, and upon removal using soap and water, very severe irritant contact dermatitis was observed with no pain to patient.After approximately 12 hours of rest and left uncovered, the wound location still presented the severe reaction.Pediatric care was then sought.Pediatrician rx cetirizine (zyrtec) to counter reaction.Also noted that subject bandages contained 0.8% bzk while children's bandages by same manufacturer contain 0.1% bzk as possible source of irritation.Wound location continues to heal 7 days after last use/removal of bandage, with observable improvement in first 24 hours.Fda safety report id # (b)(4).

• Brand Name: ANTIBACTERIAL FLEXIBLE FABRIC MEDIUM BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WALGREENS BOOTS ALLIANCE, INC.; 108 wilmot road; deerfield IL 60015
• MDR Report Key: 14257495
• MDR Text Key: 290560674
• Report Number: MW5109457
• 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: Unknown
• Type of Report: Initial
• Report Date: 04/27/2022

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 Expiration Date: 12/20/2022
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2022
• Patient Sequence Number: 1
• Treatment: CETIRIZINE (ZYRTEC)
• Patient Outcome(s): Other; Disability
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 18 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White