MAUDE Adverse Event Report: UNKNOWN REXALL ANTIBACTERIAL FLEXIBLE FABRIC; TAPE AND BANDAGE, ADHESIVE

Catalog Number DG00463403

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Caustic/Chemical Burns (2549); Fluid Discharge (2686)

Event Date 11/08/2022

Event Type  Injury  

Event Description

My daughter put a rexall antibacterial flexible fabric bandage on her face because she had a scratch.It ended up eating the skin off her face where the pad with the medicine was.It is a chemical burn.It burns and is seeping.We are at the dr now.Fda safety report id (b)(4).

• Brand Name: REXALL ANTIBACTERIAL FLEXIBLE FABRIC
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15800597
• MDR Text Key: 303799095
• Report Number: MW5113285
• 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: 11/09/2022

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 Catalogue Number: DG00463403
• Device Lot Number: 220301
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White