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

Model Number	UPC#681131006743
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of december 01, 2025, retained samples were submitted to the lab for testing 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 september 10, 2025, the consumer states that the product caused a burn and peeled her skin.On the completed cir received from the consumer on november 06, 2025, the consumer states that the bandages burned her skin around the wound.The consumer went to urgent care and was prescribed antibiotic cream.In the form, consumer stated the issue was with the tape area and that the symptoms corrected after she stopped using the product.

• Brand Name: EQUATE
• Common Device Name: HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota, fl 34240 ; MX 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.
• MDR Report Key: 23714671
• Report Number: 1038758-2025-00032
• Device Sequence Number: 8982099
• Product Code: KGX
• UDI-Device Identifier: 00681131006743
• UDI-Public: 00681131006743
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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
• Device Lot Number: 246438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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