MAUDE Adverse Event Report: ASO LLC EQUATE; FLEXIBLE FABRIC ANTIBACTERIAL BANDAGES 1 SIZE

Model Number	UPC#681131228350
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received by aso on april 23, 2025, the consumer stated that the product caused her to experience a burn or rash.On the completed consumer information report (cir) received on may 14, 2025, the consumer stated that the product caused her to develop a raised rash, itch, and scarring after using the bandage.Consumer visited the rn on (b)(6) 2025.The rn recommended neosporin.The bandages were used to cover a mosquito bite.Per cir the issue was with the pad area.
Additional Manufacturer Narrative
As of 05/29/2025 returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on device label.

• Brand Name: EQUATE
• Common Device Name: FLEXIBLE FABRIC ANTIBACTERIAL BANDAGES 1 SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; 9413790300
• MDR Report Key: 22153217
• Report Number: 1038758-2025-00011
• Device Sequence Number: 15403470
• Product Code: KGX
• UDI-Device Identifier: 00681131228350
• UDI-Public: 00681131228350
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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
• Device Model Number: UPC#681131228350
• Device Lot Number: 183515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female