MAUDE Adverse Event Report: ASO LLC KROGER ANTIBACTERIAL STERILE SHEER ADHESIVE PADS 3" X 4"; ADHESIVE BANDAGES

Model Number 041260341793

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

Patient Problems Skin Irritation (2076); Skin Tears (2516)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

Package labeling indicates that the bandages have a medicated pad with the active ingredient - benzalkonium chloride 0.1%.Aso/manufacturer reached out to consumer/end-user to request samples of the remaining device/product by return mail for investigation and testing.10/05/2015 - end-user returned used product, however used bandages cannot be further analyzed.Unused product samples where not returned to date.10/05/2015 - the end-user provided additional information stating that event symptoms corrected after she stopped using the product.

Event Description

Customer/end-user reported that after using the device/product she experienced itching at the bandage site and her skin was peeling.End-user sought medical attention and was treated with desonate.

• Brand Name: KROGER ANTIBACTERIAL STERILE SHEER ADHESIVE PADS 3" X 4"
• Type of Device: ADHESIVE 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: steve walter ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5224732
• MDR Text Key: 31184613
• Report Number: 1038758-2015-00086
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00041260341793
• UDI-Public: 041260341793
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2015

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 Operator: Lay User/Patient
• Device Model Number: 041260341793
• Device Catalogue Number: 15573346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2015
• Initial Date FDA Received: 11/16/2015
• 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