MAUDE Adverse Event Report: ASO LLC EQUATE; SMART-FLEX ADVANCED BANDAGES

Model Number UPC#681131349796

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

Patient Problems Abrasion (1689); Skin Inflammation/ Irritation (4545)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

As of 02/19/2024 returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b.6 of this report for further details.

Event Description

On the initial report received on 01/16/2024, the consumer stated that she had a reaction to the product, which ripped off some skin and left an imprint of bandage.On the completed cir received from the consumer on 01/31/2024, she states that she used the bandages for less than 24 hours; she tried to change the bandage, but it was hard to remove, and it left an imprint of the bandage on her skin.The consumer states she went to the dermatologist.Consumer purchase creams to lighten the area.

• Brand Name: EQUATE
• Type of Device: SMART-FLEX ADVANCED BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; 9413790300
• MDR Report Key: 18757291
• MDR Text Key: 335990560
• Report Number: 1038758-2024-00003
• Device Sequence Number: 1
• Product Code: KGX
• 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: 02/22/2024

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#681131349796
• Device Catalogue Number: 063621
• Device Lot Number: 00187463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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