MAUDE Adverse Event Report: ASO LLC EQUATE; HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIDE

Model Number	UPC#681131006743
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received by aso on 04/09/2025, the consumer stated that she experienced a reaction to the product.On the completed consumer information report (cir) received on may 6, 2025, the consumer stated that the product caused her red welts under areas of the adhesive and painful sores.The consumer mentioned using a healing balm for self-care of the wound.She also used paper tape with a pad, as the doctor advised, to keep the wound covered.
Additional Manufacturer Narrative
As of 05/27/2025, 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 b6 of this report for further details.Udi notes: the expiry date is not present on device label.

• Brand Name: EQUATE
• Common Device Name: HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIDE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.
• MDR Report Key: 22100063
• Report Number: 1038758-2025-00010
• Device Sequence Number: 8448020
• Product Code: KGX
• UDI-Device Identifier: 00681131006743
• UDI-Public: 00681131006743
• 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): 05/28/2025

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#681131006743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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