MAUDE Adverse Event Report: EUROMED, INC. CVS HEALTH; ADVANCED HEALING HYDROCOLLOID PADS

Model Number UPC#050428397930

Device Problem Off-Label Use (1494)

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2019 manufacturer evaluated retained product samples with no defects noted.In addition, aso reviewed records of biocompatibility tests.

Event Description

On the initial report on (b)(6) 2019 consumer reported the damaged situation from procedure on (b)(6) 2019 reporter stated on returned cir that the product tore her stitches and she went to emergency room to get stitches reapplied.

• Brand Name: CVS HEALTH
• Type of Device: ADVANCED HEALING HYDROCOLLOID PADS
• 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: 9031894
• MDR Text Key: 161170167
• Report Number: 1038758-2019-00035
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2023
• Device Model Number: UPC#050428397930
• Device Catalogue Number: 0893118
• Device Lot Number: 00096866
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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