MAUDE Adverse Event Report: ASO LLC WALGREENS; SHEER ADHESIVE PADS

Model Number	UPC#311917205458
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report 09/23/2024, the consumer stated that the adhesive around the pad caused irritation on the arm and leg.Consumer had a doctor's appointment for another issue and was told to use an antibiotic ointment.Before the arm started to break, the consumer used 14 bandages (2 per day for 7 days).Her arm started to itch, and she started noticing little bumps on her arm.The consumer returned the customer information request (cir) on 02/27/2025.The consumer informed that she used the product after grease splashed on her arm and leg when cooking.Consumer stated that treatment was required.Consumer went to the urgent care, and the doctor advised to get over-the-counter burn cream.Consumer stated that the issue was with the tape area.The adhesive area of the patch left an allergic reaction on her arm and leg.In addition, consumer confirmed that symptoms corrected after she stopped using the product.
Additional Manufacturer Narrative
The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on 2/27/2025 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 03/10/2025 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.Udi notes: the expiry date is not present on the device label.

• Brand Name: WALGREENS
• Common Device Name: SHEER ADHESIVE PADS
• 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: 21560949
• Report Number: 1038758-2024-00036
• Device Sequence Number: 4375144
• Product Code: KGX
• UDI-Device Identifier: 00311917205458
• UDI-Public: 00311917205458
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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#311917205458
• Device Catalogue Number: ITEM # 109881
• Device Lot Number: 00181865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female