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

Model Number UPC#041260384103

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

Patient Problems Abrasion (1689); Rash (2033)

Event Date 09/22/2023

Event Type  Injury  

Event Description

On the initial report on (b)(6) 2023, the consumer stated that she believed she was allergic to the product.She realized that the bandage peeled off a layer of her skin.The consumer returned the customer information request (cir) on (b)(6) 2023.The consumer stated that she did not receive treatment for the torn skin.She received a steroid cream that the doctor prescribed for the rash.In addition, the consumer confirmed that the issue was with the tape area.

Manufacturer Narrative

As of (b)(6) 2023 unused retained/returned product was submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to section b.6 of this report for further details.

• Brand Name: KROGER
• Type of Device: ADVANCED ANTIBACTERIAL SHEER 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 34204
• MDR Report Key: 17978874
• MDR Text Key: 326240897
• Report Number: 1038758-2023-00027
• 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: 10/20/2023

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#041260384103
• Device Lot Number: 00179517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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