MAUDE Adverse Event Report: ASO LLC CVS; MAXFLEX SENSITIVE SKIN ALL ONE SIZE

Model Number	UPC#050428475041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 04/29/2025 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.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on device label.
Event or Problem Description
On the initial report received by aso on 03/26/2025 consumer stated that product ripped her skin.On the completed consumer information report (cir) received on 04/08/2025, the consumer stated that she used the bandage to cover a wound on her left breast.The bandage ripped her skin off and now has a permanent scar on her chest.Treatment was required.The consumer went to the dermatologist that informed that area needed to be healed.In addition, the consumer states the issue was with the tape area and that the symptoms did not correct after she stopped using the product.

• Brand Name: CVS
• Common Device Name: MAXFLEX SENSITIVE SKIN ALL ONE SIZE
• 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: 300 sarasota center blvd.; 9413790300
• MDR Report Key: 21959739
• Report Number: 1038758-2025-00009
• Device Sequence Number: 9197538
• Product Code: KGX
• UDI-Device Identifier: 00050428475041
• UDI-Public: 00050428475041
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/05/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: UPC#050428475041
• Device Catalogue Number: 596731
• Device Lot Number: 226835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2024
• 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