MAUDE Adverse Event Report: EUROMED, INC. WALGREENS; HYDROCOLLOID GEL BANDAGES ONE SIZE

Model Number	UPC#311917193533
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report dated (b)(6)2024, the consumer stated that the product burned her hand and left scars.On the completed cir received from the consumer on (b)(6)2024, the consumer stated that she used the product on her hand, and when she removed it, her hand was burned.The consumer sent the documents for her doctor's visit on (b)(6) 2024.The consumer was prescribed with cephalexin 500mg capsule and antibiotic ointment.
Additional Manufacturer Narrative
As of 12/03/2024 manufacturer has completed their investigation with no issues found.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.Pms (post market surveillance) has been reviewed for the past two years (2022 -2023); no negative trend was identified for the associated product.

• Brand Name: WALGREENS
• Common Device Name: HYDROCOLLOID GEL BANDAGES ONE SIZE
• 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: 20836901
• Report Number: 1038758-2024-00030
• Device Sequence Number: 8502040
• Product Code: NAD
• UDI-Device Identifier: 00311917193533
• UDI-Public: 00311917193533
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/03/2024

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 Expiration Date: 10/01/2026
• Device Model Number: UPC#311917193533
• Device Catalogue Number: 990443
• Device Lot Number: 00179637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 98 KG