MAUDE Adverse Event Report: ASO LLC equate; Flexible Fabric Antibacterial Bandages All one size

Model Number	UPC#681131228350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of (b)(6) 2026, 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.
Event or Problem Description
On the initial report received on (b)(6) 2026, the consumer stated that she experienced a skin reaction to the bandage, including a reddish ring around the bandage.She also reported that she had already notified her physician.

• 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.; +1(941)379-0300
• MDR Report Key: 50950921
• Report Number: 1038758-2026-00026
• Device Sequence Number: 18754989
• Product Code: KGX
• UDI-Device Identifier: 00681131228350
• UDI-Public: 00681131228350
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K983368
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Catalogue Number: 566944586
• Device Lot Number: 263142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2026
• 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