MAUDE Adverse Event Report: FERRIS MFG. CORP. POLYMEM; POLYMEM DRESSING

Model Number	5044
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported polymem adhered to the patient's wound and was unable to be removed with saline, thus requiring manual débridement with a dermal curette.The healthcare professional observed healthy epithelial tissue after dressing removal.

• Brand Name: POLYMEM
• Common Device Name: POLYMEM DRESSING
• Manufacturer (Section D): FERRIS MFG. CORP.; 5133 northeast parkway; fort worth 76106
• Manufacturer (Section G): FERRIS MFG. CORP.; 5133 northeast parkway; fort worth TX 76106
• Manufacturer Contact: adair claycomb ; 5133 northeast parkway; fort worth, TX 76106 ; 8179001306
• MDR Report Key: 22917291
• Report Number: 1419520-2025-00001
• Device Sequence Number: 15891657
• Product Code: KMF
• UDI-Device Identifier: 10735471050441
• UDI-Public: (01)10735471050441
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: 5044
• Device Catalogue Number: 5044
• Device Lot Number: 19024E2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 07/08/2024
• 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: Required Intervention
• Patient Sex: Female