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

Model Number	UPC#681131006729
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received by aso on november 01, the consumer stated that her husband had an allergic reaction to the product.On the completed consumer information report (cir) received on december 01, 2025, the consumer reported a reaction to the product.The consumer went to the patient 1st urgent care.Per cir, the issue was with the tape and pad of the bandage.The consumer confirmed that the symptoms resolved after stopping use of the product.
Additional Manufacturer Narrative
As of 12/22/2025, 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.
Additional Manufacturer Narrative
As of 12/22/2025, 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 b6 of this report for further details.As of 01/12/2026, unused returned product was submitted to the lab for testing with no defects noted.Refer to section b6 of this report for further details.The following sections were updated: b6, g6, h2, and h6 (medical device problem code has been updated from 1670 to 2993).Udi notes: the expiry date is not present on device label.
Event or Problem Description
According to the initial report received by aso on november 01, the consumer stated that her husband had an allergic reaction to the product.On the completed consumer information report (cir) received on december 01, 2025, the consumer reported a reaction to the product.The consumer went to the patient 1st urgent care.Per cir, the issue was with the tape and pad of the bandage.The consumer confirmed that the symptoms resolved after stopping use of the product.

• 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: 23905347
• Report Number: 1038758-2025-00034
• Device Sequence Number: 18648109
• Product Code: KGX
• UDI-Device Identifier: 00681131006729
• UDI-Public: 00681131006729
• 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,Followup
• Report Date (Section B): 01/22/2026

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#681131006729
• Device Lot Number: 247337
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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: Male