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

Lot Number 00205374

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Blister (4537)

Event Date 03/22/2024

Event Type  Injury  

Event Description

Using walmart's equate brand of heavy duty fabric bandages my right arm wound, my arm developed an allergic reaction to the bandage causing burning and blistering.Refer to add'l documents in i2k.

• Brand Name: EQUATE HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WALMART STORES; 702 southwest 8th st.; bentonville AR 72716
• MDR Report Key: 18991132
• MDR Text Key: 338888961
• Report Number: MW5153289
• 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: 03/24/2024

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?: No
• Device Lot Number: 00205374
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2024
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN .; LOSARTAN.; ONE A DAY VITAMINS.
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White