MAUDE Adverse Event Report: ASO LLC CVS HEALTH; CLEAR WATERPROOF ANTIBACTERIAL BANDAGES ASSORTED SIZES

Model Number	UPC#050428399750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received on february 11, 2026, the consumer reported that the product caused side effects.On the completed consumer information request form (cir) received on february 27, 2026, the consumer stated that the area of her skin beneath the bandage pad began to turn red and became irritated.The consumer went to a dermatologist.Per the cir, the issue was with the pad area.The dermatologist prescribed clobetasol propionate 0.05% to be applied to the red, irritated skin twice daily for 2 weeks.The consumer confirmed that the symptoms resolved after she stopped using the product.The cream cleared the irritated skin.
Additional Manufacturer Narrative
As 3/17/2026, 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.

• Brand Name: CVS HEALTH
• Common Device Name: CLEAR WATERPROOF ANTIBACTERIAL 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.
• MDR Report Key: 24634268
• Report Number: 1038758-2026-00009
• Device Sequence Number: 8688533
• Product Code: KGX
• UDI-Device Identifier: 00050428399750
• UDI-Public: 0050428399750
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K983368
• 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): 03/18/2026

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#050428399750
• Device Catalogue Number: 325406
• Device Lot Number: 222792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2024
• 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