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

Model Number UPC#041260384035

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2022 aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.Refer to section of this report for further details.

Event Description

Consumer stated on (b)(6) 2022 that product a severe reaction.Consumer returned consumer information report (cir) on (b)(6) 2022.Consumer stated that after using the product, the area became itchy.There were raised red itchy bumps all around the area were product was used.Consumer informed that she required medical treatment.She contacted her provider who recommended a itchy cream.Consumer confirmed that the issue was with the tape area.

Event Description

Consumer stated on 11/17/2022 that product a severe reaction.Consumer returned consumer information report (cir) on 11/22/2022.Consumer stated that after using the product, the area became itchy.There were raised red itchy bumps all around the area were product was used.Consumer informed that she required medical treatment.She contacted her provider who recommended a itchy cream.Consumer confirmed that the issue was with the tape area.

Manufacturer Narrative

As of 12/21/2022 aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.Refer to section b.6 of this report for further details.As of 03/06/2023 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.

• Brand Name: KROGER
• Type of Device: ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES ALL ONE SIZE
• 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: 16023101
• MDR Text Key: 305895691
• Report Number: 1038758-2022-00050
• 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: 03/31/2023

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#041260384035
• Device Lot Number: 0016222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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