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

Model Number UPC#050428373668

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/26/2022

Event Type  Injury  

Event Description

On the initial report on (b)(6) 2022 consumer stated that product caused a reaction (blisters) on her foot.On completed cir received from consumer on (b)(6) 2022 she stated applied the product to her foot over a wart that had been removed.She added she felt pain and there was a blister.She washed the area and tried again and got a second blister.Consumer stated sought medical attention with a dermatologist who prescribed clobetasol propionate ointment.The consumer stated the symptoms did not immediately stopped after discontinued use of the product, but is slowly getting better (consumer still had a blister).

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on (b)(6) 2022 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of (b)(6) 2022 manufacturer has not finished their investigation.Aso reviewed records of biocompatibility tests with no issues noted.

Event Description

On the initial report on 07/12/2022 consumer stated that product caused a reaction (blisters) on her foot.On completed cir received from consumer on 07/26/2022 she stated applied the product to her foot over a wart that had been removed.She added she felt pain and there was a blister.She washed the area and tried again and got a second blister.Consumer stated sought medical attention with a dermatologist who prescribed clobetasol propionate ointment.The consumer stated the symptoms did not inmediatelly stopped after discontinued use of the product, but is slowly getting better (consumer still had a blister).

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on 07/26/2022 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 08/19/2022 manufacturer has not finished their investigation.Aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.As of 10/04/2022 manufacturer has completed their investigation with no issues found.Please refere to b6 for details.The following sections were updated: b6; g6; h2; h3; h6 (type of investigation; investigation findings; investigation conclusions).

• 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: 15282721
• MDR Text Key: 298477006
• Report Number: 1038758-2022-00034
• 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,Followup
• Report Date: 10/06/2022

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#050428373668
• Device Catalogue Number: 959039
• Device Lot Number: 00151390
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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: Female