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

Model Number	1088
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient has a large plantar foot wound and 24 hours post application, the dressing disintegrated in the wound.

• Brand Name: POLYMEM SILVER MAX
• Common Device Name: POLYMEM SILVER MAX DRESSING
• Manufacturer (Section D): FERRIS MFG. CORP.; 5133 northeast parkway; fort worth TX 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: 22930931
• Report Number: 1419520-2025-00002
• Device Sequence Number: 18730490
• Product Code: FRO
• UDI-Device Identifier: 10735471010889
• UDI-Public: (01)10735471010889
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1088
• Device Catalogue Number: 1088
• Device Lot Number: 10025A1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown