MAUDE Adverse Event Report: EUROMED, INC. CVS HEALTH; HYDROCOLLOID BLISTER CARE CUSHIONS

Model Number UPC#050428253212

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

Patient Problem Abrasion (1689)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

As of 06/03/2019 aso could not confirm the lot number for additional investigation.Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed.Refer to b.6 for further details.Complaint database was reviewed; there was no negative trend identified for the associated product.

Event Description

Consumer stated that product was stuck completely to wound.Consumer reported that she went to the urgent care for assistance and it was excruciatingly painful.She received prescription antibacterial cream and nonstick gauze.

• Brand Name: CVS HEALTH
• Type of Device: HYDROCOLLOID BLISTER CARE CUSHIONS
• 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: 8711897
• MDR Text Key: 148416280
• Report Number: 1038758-2019-00016
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#050428253212
• Device Catalogue Number: 262332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• 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