MAUDE Adverse Event Report: EQUATE VARIETY PACK ASSORTED BANDAGES ANTIBACTERIAL; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/09/2023

Event Type  Injury  

Event Description

My 3 year old son had a bandage on for one day.He developed a reaction (in the shape of the bandage).It burned his skin off.

• Brand Name: EQUATE VARIETY PACK ASSORTED BANDAGES ANTIBACTERIAL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 16930236
• MDR Text Key: 315292499
• Report Number: MW5117525
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/10/2023

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2023
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Male