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

Model Number	UPC#681131006729
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received by aso on july 25, 2025, the consumer stated that the product caused her an allergic reaction to the wound after her surgery.On the completed consumer information report (cir) received on august 18, 2025, the consumer stated that she had a stomach surgery on (b)(6) and used the bandages to help cover the wounds.She experienced an allergic reaction.The consumer contacted her doctor, who advised her to apply a cream to the affected area, but it did not help.The consumer visited a dermatologist, who prescribed a cream and instructed her to apply it to the area twice a day, or more as needed.Per cir the issue was with the tape area of the bandage.The consumer confirmed that the symptoms corrected after she stopped using the product.
Additional Manufacturer Narrative
As of 08/18/2025, 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 ALL ONE 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: 22841593
• Report Number: 1038758-2025-00019
• Device Sequence Number: 11993631
• Product Code: KGX
• UDI-Device Identifier: 00681131006729
• UDI-Public: 00681131006729
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/19/2025

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#681131006729
• Device Lot Number: 233924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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