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

Model Number	UPC#681131006743
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abrasion (1689); Skin Inflammation/ Irritation (4545)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 09/11/2025, aso was unable to retrieve the lot number information or unused return product.Aso reviewed records of biocompatibility tests, latex screening test with no issues reported.Refer to section b.6 of this report for further details.Complaint history and trend analysis for this product were reviewed.The analysis did not identify any trends in complaint occurrence.The manufacturer will continue to monitor complaint data as part of routine post-market surveillance activities in accordance with established procedures and applicable regulatory requirements.
Event or Problem Description
According to the initial report received by aso on august 19, 2025, the consumer stated that her 5-year-old son used the bandages on his leg after rubbing it against the pool edge.The next evening, he woke up screaming in pain.They removed the bandage, and he has a chemical burn, with blisters, redness, and swelling in the area that the bandage pad previously covered.The skin had been ripped off where the adhesive was.Per the initial report, the consumer stated that the issue was with the pad and tape area.His doctor and the patient's mom were trying to determine whether he was allergic to something in the bandage.

• 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: 23083083
• Report Number: 1038758-2025-00022
• Device Sequence Number: 10065028
• 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): 09/18/2025

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: 08/19/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 5 YR
• Patient Sex: Male