MAUDE Adverse Event Report: SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. CVS HEALTH; STERILE NON-STICK PADS

Model Number	UPC#050428307274
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 03/03/2025 manufacturer evaluated retained samples of the same lot reported with no defects noted.The lab report was received for returned product.The absorbency results on the samples were within range of specification m-242, rev.02.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report dated 01/21/2025, the consumer stated that the product stuck to her wound and tore her skin, causing her to bleed.On the completed cir received from the consumer on 02/24/2025, she mentioned having a wound on her arm.Consumer stated that treatment was required.The doctor recommended covering the wound with a non-stick pad.However, upon changing the pad, it tore her skin off.The consumer consulted the doctor again and was prescribed antibiotic cream and oral medication.Consumer confirmed that symptoms corrected after stopping using the product.

• Brand Name: CVS HEALTH
• Common Device Name: STERILE NON-STICK PADS
• Manufacturer (Section D): SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO.; no.18, zhihe dong road; suzhou industrial park; suzhou, 21512 2; CH 215122
• 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: 21527935
• Report Number: 1038758-2025-00004
• Device Sequence Number: 9584926
• Product Code: NAC
• UDI-Device Identifier: 00050428307274
• UDI-Public: 00050428307274
• 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): 03/03/2025

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#050428307274
• Device Catalogue Number: 935683
• Device Lot Number: 2384-20231015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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