MAUDE Adverse Event Report: ASO LLC WALGREENS; SMART-FLEX ADHESIVE BANDAGES ASSORTED SIZES

Model Number UPC#311917195254

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

Patient Problem Blister (4537)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2022 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.Refer to section b.6 of this report for further details.

Event Description

Consumer stated on (b)(6) 2022 that product caused blister on her skin.Consumer returned customer information request (cir) on (b)(6) 2022.Consumer informed that she was using the product to cover stitches.Consumer stated that she required treatment.It was prescribed triamcinolone acetonide cream.Consumer stated that the symptoms corrected after stopping using the product.In addition, consumer confirmed that the issue was with the tape area.

• Brand Name: WALGREENS
• Type of Device: SMART-FLEX ADHESIVE BANDAGES ASSORTED SIZES
• 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: 15959652
• MDR Text Key: 305265730
• Report Number: 1038758-2022-00048
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UPC#311917195254
• Device Catalogue Number: 884646
• Device Lot Number: 00161732
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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