MAUDE Adverse Event Report: EUROMED, INC. CVS; HYDROCOLLOID GEL ADHESIVE PADS

Model Number	UPC#050428251966
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report dated on (b)(6) 2025, the consumer stated that the product caused her burns.She had to take prednisone, and her wound was still healing, and she had a discoloration on her leg.On the completed cir received via email from the consumer on may 2, 2025, the consumer states that the entire area of the bandage wound has blisters and a raised skin rash.The consumer visited the doctor and was prescribed prednisone 10mg tablets, hydroxyzine hci 25mg, and betamethasone valerate 0.1% topical cream.
Additional Manufacturer Narrative
As of 05/29/2025, a manufacturer has completed their investigation with no issues found.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b6 of this report for further details.

• Brand Name: CVS
• Common Device Name: HYDROCOLLOID GEL ADHESIVE PADS
• 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: 22105935
• Report Number: 1038758-2025-00012
• Device Sequence Number: 8139565
• Product Code: NAD
• UDI-Device Identifier: 00050428251966
• UDI-Public: 00050428251966
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/29/2025

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#050428251966
• Device Catalogue Number: 893118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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