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 Problem Rash (2033)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

As of 02/16/2021 manufacturer has not finished their investigation and patient is undergoing a "patch test" to try to determine what ingredient may have caused the reaction.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 (rash, redness and swelling) on her (b)(6) daughter's face after applying the hydrocolloid product to her face.Consumer sought medical attention after trying herself to treat unsuccessfully with benadryl and hydrocortisone ointment.Her doctor prescribed some strong steroids which helped it go away after about ten days.Doctor believes she may have developed an allergic reaction to the product.

• 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: 11348379
• MDR Text Key: 232549078
• Report Number: 1038758-2021-00006
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 00124161
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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 Age: 15 YR