MAUDE Adverse Event Report: EUROMED, INC. WALGREENS; STERILE ASSORTED BLISTER CUSHIONS

Model Number	UPC# 311917195667
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 02/23/2026 aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.
Event or Problem Description
According to the initial report received on january 13, 2026, the consumer stated that the product caused injured on her toe after running a marathon.In the completed customer information request (cir) form submitted on (b)(6) 2026, the consumer reported that she wrapped the product around her right foot, as she always does, and ran a marathon.She experienced stinging pain during the run; upon finishing and removing her shoes, she noticed that her foot was bleeding.The consumer went to the medic tent, and was informed that the plaster had ripped off her skin during the run, causing a deep abrasion.The consumer confirmed that the symptoms corrected after she stopped using the product.The area has been treated, and the wound is healing.

• Brand Name: WALGREENS
• Common Device Name: STERILE ASSORTED BLISTER CUSHIONS
• Manufacturer (Section D): EUROMED, INC.; 25 corporate drive; orangeburg NY 10962
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 24427740
• Report Number: 1038758-2026-00004
• Device Sequence Number: 15885544
• Product Code: NAD
• UDI-Device Identifier: 00311917195667
• UDI-Public: 00311917195667
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/24/2026

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# 311917195667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/24/2026
• 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 Sex: Female