MAUDE Adverse Event Report: EUROMED, INC. CVSPHARMACY; ADVANCED HEALING PREMIUM BANDAGES

Model Number UPC#050428171240

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Aso has reviewed records of biocompatibility tests as well as manufacturer's tests with no issues reported.Manufacturer stated that there is no evidence of a trend associated with the bandages that would indicate an increased risk to user safety.Aso complaint database was reviewed; there was no (b)(6) trend identified for the associated product.Refer this report for further details.

Event Description

The initial report on (b)(6) 2018 consumer informed that product was used to cover burn.Customer stated that she feels that burn may have got worse after using the product.Consumer stated that she has removed bandage and product ripped her skin around burn area.Costumer requested composition of bandage.The completed customer information request (cir) was received on 09/24/2018.Consumer stated that she removed bandage within the first day as the bandage did not seal properly.Customer required medical treatment and the symptoms did not correct after she stopped using the product.Her doctor prescribed a burn ointment and antibiotics.

• Brand Name: CVSPHARMACY
• Type of Device: ADVANCED HEALING PREMIUM 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: 7954248
• MDR Text Key: 123359230
• Report Number: 1038758-2018-00028
• 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: 09/10/2018

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 Operator: No Information
• Device Expiration Date: 01/07/2017
• Device Model Number: UPC#050428171240
• Device Catalogue Number: 371579
• Device Lot Number: 00007247
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other