MAUDE Adverse Event Report: ASO LLC EQUATE SKIN TONE BAND AID; TAPE AND BANDAGE, ADHESIVE

Patient Problems Hemorrhage/Bleeding (1888); Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 09/14/2023

Event Type  Injury  

Event Description

My son used a band aid from equate skin tone box and it cause him to have a burn in the shape on the band aid on the area it was placed.The area blistered and bleed.

• Brand Name: EQUATE SKIN TONE BAND AID
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC
• MDR Report Key: 17863099
• MDR Text Key: 324887459
• Report Number: MW5146468
• 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: 09/28/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American