MAUDE Adverse Event Report: MESH; MESH, SURGICAL, POLYMERIC

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bacterial Infection (1735); Impaired Healing (2378)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I had a surgery for a hernia and the hospital used dermaklenz on my wound in the hospital and i was also sent home from the hospital with a bottle of dermaklenz.I received a notice it has been recalled.The bottle that the hospital sent me home with is part of the recall.I am still as of today (b)(6) 2025 still dealing with the wound not healing.I also was told at my second surgery i had mrsa (methicillin-resistant staphylococcus aureus).I am now on antibiotics again and am concerned it may be because this recalled product was the reason for my infections?? the hospital where i have now had 3 surgeries due to my wound not healing was (b)(6).My contact information (b)(6).

• Brand Name: MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 23170655
• Report Number: MW5176756
• Device Sequence Number: 9183245
• Product Code: FTL
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/23/2025

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other; Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White