MAUDE Adverse Event Report: ASO AMERICAS, S. DE R. L. DE C. V. KROGER; ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES ALL ONE SIZE

Model Number UPC#041260384028

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2023 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

Consumer stated on (b)(6) 2022 that product caused an allergic reaction.On (b)(6) 2022 aso received an email from the company representative that consumer went to the doctor for treatment.

• Brand Name: KROGER
• Type of Device: ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES ALL ONE SIZE
• Manufacturer (Section D): ASO AMERICAS, S. DE R. L. DE C. V.; centro industrial juarez; rio michigan, 9730; juarez, chihuahua 32648 ; MX 32648
• 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: 16162217
• MDR Text Key: 307464173
• Report Number: 1038758-2022-00054
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UPC#041260384028
• Device Lot Number: 00165229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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