MAUDE Adverse Event Report: ASO LLC CVS HEALTH; STERILE WATERPROOF ADHESIVE PADS

Model Number	UPC#050428271766
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received by aso on (b)(6) 2026, the consumer reported observing "black mold" appearing on the bandage during use.On the same day, an additional email was received from the consumer stating that the product had been returned to the store.The consumer indicated that the bandage had been applied to a surgical wound and that the product had been recommended by her surgeon.As a precautionary measure related to the consumer's reported observation, the physician prescribed antibiotics.
Additional Manufacturer Narrative
As of 05/18/2026, the returned/retained product was inspected, and no mold-related defects in the bandages were 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: STERILE WATERPROOF 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
• MDR Report Key: 25240414
• Report Number: 1038758-2026-00012
• Device Sequence Number: 13152287
• Product Code: KGX
• UDI-Device Identifier: 00050428271766
• UDI-Public: 00050428271766
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/21/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: UPC#050428271766
• Device Catalogue Number: #893124
• Device Lot Number: 24735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2024
• 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