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

Model Number UPC#041260384028

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

Patient Problem Abrasion (1689)

Event Date 05/15/2023

Event Type  Injury  

Event Description

On the initial report received by aso on 05/15/2023, the consumer states that the fabric bandage tore his skin and caused an infection, which required medical treatment.The consumer states that he is still having the after-effects of the reaction.

Manufacturer Narrative

As of (b)(6) 2023 retained samples of the same lot product were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.

Manufacturer Narrative

As of 06/05/2023 retained samples of the same lot product were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.As 8/02/2023 aso received completed cir and unused products from the consumer.Unused product 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.The following sections were updated: b5, b6, g6, h3, h6.

Event Description

On the initial report received by aso on 05/15/2023, the consumer states that the fabric bandage tore his skin and caused an infection, which required medical treatment.The consumer states that he is still having the after-effects of the reaction.The consumer returned consumer information report (cir) on (b)(6) 2023.The consumer stated that after using the product, the area became itchy, burning, sticky, and tore his skin.He stated his issue was with the pad and the tape area.

• Brand Name: KROGER
• Type of Device: ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES EXTRA LARGE 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.
• MDR Report Key: 17071284
• MDR Text Key: 316658053
• Report Number: 1038758-2023-00012
• 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,Followup
• Report Date: 08/02/2023

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#041260384028
• Device Lot Number: 00177585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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: Male