MAUDE Adverse Event Report: WALMART STORES EQUATE FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL; TAPE AND BANDAGE, ADHESIVE

Lot Number 220501

Device Problem Use of Device Problem (1670)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/21/2023

Event Type  Injury  

Event Description

Applied bandage to cover shingles lesion and experienced allergic reaction or burns (presumably from the adhesive).Bandage was contained with antibacterial.Applied as medicated patch to skin.Dates of use: (b)(6) 2023.Reason for use: covering shingles lesion to reduce potential spread to other.The problem stopped after the person reduced the dose or stopped taking or using the product; didn't restart.

• Brand Name: EQUATE FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WALMART STORES; 601 north walton blvd.; mail stop 0410; bentonville AR 72716
• MDR Report Key: 17011134
• MDR Text Key: 316109119
• Report Number: MW5117921
• 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: Patient
• Type of Report: Initial
• Report Date: 05/23/2023

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
• Device Lot Number: 220501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Patient Sequence Number: 1
• Treatment: AMLODIPINE ; BENAZEPRIL; CALCIUM; MULTIVITAMIN/MINERAL; VIT D3
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American