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

Model Number	UPC#681131006736
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received by aso on 11/26/2024, the consumer stated that the product made her skin hard, and her skin started to peel on her finger only where the bandage was.In the completed consumer information report (cir) received on 01/03/2025, the consumer states that she used the bandages on a cut, which worsened, and caused irritation to all the surrounding skin.The consumer stated that she required medical treatment and that the symptoms did not improve after she stopped using the product.Consumer stated that the skin on her hand has healed, but it is extremely hard to bend her index finger.
Additional Manufacturer Narrative
As of 01/27/2025 returned and 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 the device label.

• 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
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 21268521
• Report Number: 1038758-2024-00034
• Device Sequence Number: 11684540
• Product Code: KGX
• UDI-Device Identifier: 00681131006736
• UDI-Public: 00681131006736
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 01/27/2025

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#681131006736
• Device Catalogue Number: 566928026
• Device Lot Number: 224295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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