MAUDE Adverse Event Report: QIDONG FARJOY MEDICAL MATERIAL CO LTD CVS HEALTH; WATERPROOF TRANSPARENT DRESSINGS

Model Number	UPC#050428378533
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 11/25/2025 manufacturer evaluated retained samples of the same lot reported with no defects noted.In addition, aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.
Event or Problem Description
On the initial report received on (b)(6) 2025, the consumer stated that the bandage fell off and the adhesive remained stuck on her skin.The adhesive has not come off her skin for the past 4-6 weeks.Her skin looks shiny and red.On (b)(6) 2025, the consumer reported during a phone call that she had gone to the doctor because her skin remained red and shiny.The doctor prescribed antibiotics and referred her to a wound specialist.
Additional Manufacturer Narrative
As of 11/25/2025, manufacturer evaluated retained samples of the same lot reported with no defects noted.In addition, aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.As of 12/22/2025, unused returned product was submitted to the lab for testing with no defects noted.The following sections were updated: b5, b6, g6, and h6.
Event or Problem Description
On the initial report received on october 10, 2025, the consumer stated that the bandage fell off and the adhesive remained stuck on her skin.The adhesive has not come off her skin for the past 4-6 weeks.Her skin looks shiny and red.On november 03, 2025, the consumer reported during a phone call that she had gone to the doctor because her skin remained red and shiny.The doctor prescribed antibiotics and referred her to a wound specialist.On the completed cir received from the consumer on december 1, 2025, the consumer stated that she applied the bandage to her leg and, when she removed it, the adhesive adhered to her leg.Her skin was red and shiny.The doctor ordered 10 days of antibiotics and recommended the consumer to see a wound specialist.Consumer stated that the symptoms did not correct after she stopped using the product.

• Brand Name: CVS HEALTH
• Common Device Name: WATERPROOF TRANSPARENT DRESSINGS
• Manufacturer (Section D): QIDONG FARJOY MEDICAL MATERIAL CO LTD; no 1858 nanyuan west rd; economic development zone; qidong city, jiangsu 22620 0; CH 226200
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; 9413790300
• MDR Report Key: 23657140
• Report Number: 1038758-2025-00031
• Device Sequence Number: 4824698
• Product Code: KGX
• UDI-Device Identifier: 00050428378533
• UDI-Public: 00050428378533
• 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,Followup
• Report Date (Section B): 12/29/2025

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#050428378533
• Device Catalogue Number: 894077
• Device Lot Number: 3385-20230219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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