MAUDE Adverse Event Report: EUROMED, INC. CVS HEALTH; ADVANCE HEALING HYDROCOLLOID BANDAGES

Model Number UPC#050428373668

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

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

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

As of 03/19/2021 manufacturer has not finished their investigation.Aso reviewed records of biocompatibility tests with no issues noted.

Event Description

On the initial report on (b)(6) 2021 consumer stated that product caused an allergic reaction on her arm.On email received from consumer on (b)(6) 2021 consumer stated she applied the product to her arm which had a skin irritation and it caused blistering and a burn sensation to the area.She stated consulted with her doctor and required to take an antihistamine daily for 3 weeks and the use of hydrocortisone cream for the same length of time.

• Brand Name: CVS HEALTH
• Type of Device: ADVANCE HEALING HYDROCOLLOID 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 11529494
• MDR Text Key: 241061311
• Report Number: 1038758-2021-00010
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#050428373668
• Device Catalogue Number: 959039
• Device Lot Number: 00134863
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2020
• 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