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

Model Number UPC#041260384028

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 05/03/2022

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2022 aso has no received returned samples from consumer or lot info.However, aso reviewed records of biocompatibility tests and latex screening with no issues noted.

Event Description

On the initial report received by aso on (b)(6) 2022 consumer reported that the product ripped her skin off.We received completed customer information request (cir) from the consumer on (b)(6) 2022.Consumer stated that she sought medical attention.Doctor prescribed antibiotic ointment.Consumer stated the symptoms corrected after she stopped using the product.In addition, consumer stated that the issue was with the tape area.

• 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: federico juliao ; 300 sarasota center blvd; sarasota, FL 34240
• MDR Report Key: 14525292
• MDR Text Key: 292840488
• Report Number: 1038758-2022-00020
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#041260384028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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