MAUDE Adverse Event Report: WAL-MART STORES INC. EQUATE VARIETY PACK ASSORTED BANDAGES ANTIBACTERIAL; TAPE AND BANDAGE, ADHESIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Vomiting (2144); Blister (4537)

Event Date 01/12/2023

Event Type  Injury  

Event Description

Bandage applied to a small mosquito bite on my daughter's face on (b)(6).She said it was itchy but we didn't think much of it due to the mosquito bite.She had low appetite over the day on (b)(6) and eventually experienced vomiting.Upon removing the bandage morning of (b)(6) found a rash under the adhesive area and chemical burn/blisters under the absorbent area.Rash began improving with removal, chemical burn will require further topical treatment and monitoring.(b)(6).

• Brand Name: EQUATE VARIETY PACK ASSORTED BANDAGES ANTIBACTERIAL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WAL-MART STORES INC.; 702 southwest 8th st; bentonville AR 72716
• MDR Report Key: 16195435
• MDR Text Key: 307729121
• Report Number: MW5114363
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/13/2023

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: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NATURAL CALM MAGNESIUM DRINK MIX 1 SCOOP/DAY.
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 17 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White