MAUDE Adverse Event Report: ASO LLC KROGER; ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES

Model Number UPC#041260384028

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

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

As of 08/25/2022 unused returned product and retained samples of the same lot as the reported were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.

Event Description

On the initial report received by aso on (b)(6) 2022 consumer reported that product tore her skin off.Consumer sought medical attention with her dermatologist.Consumer stated she originally placed the bandage to cover the site where an spot was removed, and upon removal the product pulled her skin off.

• Brand Name: KROGER
• Type of Device: ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC 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: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 15321061
• MDR Text Key: 298892725
• Report Number: 1038758-2022-00036
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#041260384028
• Device Catalogue Number: 032936
• Device Lot Number: 00161157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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