MAUDE Adverse Event Report: EUROMED, INC. CORE VALUES; SMART-HEAL HYDROCOLLOID GEL BANDAGES

Model Number UPC#017276235326

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Burning Sensation (2146)

Event Date 06/14/2022

Event Type  Injury  

Event Description

On the initial report on 06/14/2022 consumer stated that product caused a reaction similar to chemical burns.Consumer stated sought medical attention with her dermatologist due to the issue.

Manufacturer Narrative

As of 07/08/2022 no lot or returned product were provided therefore manufacturer is unable to perform an investigation.Aso reviewed records of biocompatibility tests with no issues noted.

• Brand Name: CORE VALUES
• Type of Device: SMART-HEAL HYDROCOLLOID GEL BANDAGES
• 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 complaiints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 15008736
• MDR Text Key: 295861103
• Report Number: 1038758-2022-00028
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#017276235326
• Device Catalogue Number: 017276235326
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female