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	Rash (2033)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 01/30/2026 manufacturer evaluated retained samples of the same lot reported with no defects noted.Aso reviewed records of biocompatibility tests with no issues reported.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on the device label.
Event or Problem Description
On the initial report dated december 12, 2025, the consumer stated that his wife had a skin reaction to the product.On the completed customer information request (cir) received from the consumer on january 19, 2026, the consumer reported that after covering an abrasion with pads for three nights, an itchy rash developed at the site of pad contact.The consumer stated that treatment was required.Duobrii lotion 0.01%/0.045% was applied as prescribed by her physician, as well as otc cortizone cream until the rash resolved.The consumer also confirmed that the symptoms stopped after 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: 24316475
• Report Number: 1038758-2026-00002
• Device Sequence Number: 17561976
• Product Code: NAC
• UDI-Device Identifier: 00050428307274
• UDI-Public: 00050428307274
• 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): 02/11/2026

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#050428307274
• Device Catalogue Number: 935683
• Device Lot Number: 2384-20230202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• 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