MAUDE Adverse Event Report: ASO LLC REXALL ANTIBACTERIAL WATERPROOF ADHESIVE PAD; TAPE AND BANDAGE, ADHESIVE

Lot Number 220201

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Contact Dermatitis (4546)

Event Date 11/30/2023

Event Type  Injury  

Event Description

This bandage caused significant contact dermatitis and pain not related to the adhesive.The bandage was worn by a child overnight (less than 12 hours), and removed in the morning.The dermatitis was not in the area of the adhesive, but instead where the antibacterial gauze portion had touched the skin.

• Brand Name: REXALL ANTIBACTERIAL WATERPROOF ADHESIVE PAD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC
• MDR Report Key: 18266935
• MDR Text Key: 329888764
• Report Number: MW5148749
• 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: 11/30/2023

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 Lot Number: 220201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Patient Sequence Number: 1
• Treatment: MIRALAX QD PRN.
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 24 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White