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

Model Number UPC#050428276037

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

As of 12/01/2023 aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.

Event Description

On the initial report on 11/ 08/2023, the consumer stated that the product caused an allergic reaction.The consumer went to the er; he was prescribed a steroid and anti-fungal cream to help with the itch.

• 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: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 18274682
• MDR Text Key: 329837384
• Report Number: 1038758-2023-00032
• 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: 12/06/2023

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#050428276037
• Device Catalogue Number: 210004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Male