MAUDE Adverse Event Report: ASO LLC CARE SCIENCE; ANTIBACTERIAL FLEXIBLE FABRIC ADHESIVE PADS

Model Number	UPC#017276238624
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of (b)(6) 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 the device label.
Event or Problem Description
On the initial report received by aso on 01/15/2025, the consumer stated that after using the bandages, she noticed the area getting redder and redder.The consumer went to the emergency room.The nurse practitioner and the doctor told her that they didn't think it was any spreading infection, but they thought she had some reaction to the adhesive.

• Brand Name: CARE SCIENCE
• Common Device Name: ANTIBACTERIAL FLEXIBLE FABRIC ADHESIVE PADS
• 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: 21344408
• Report Number: 1038758-2025-00001
• Device Sequence Number: 21072695
• Product Code: KGX
• UDI-Device Identifier: 00017276238624
• UDI-Public: 00017276238624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/10/2025

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#017276238624
• Device Lot Number: 223306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: Male