MAUDE Adverse Event Report: Ferris Mfg. Corp. PolyMem MAX Silver Non-Adhesive Pad Dressing; PolyMem Silver MAX

Model Number	1088
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a dressing change, a patient's wound had small pieces of polymem stuck to the wound.Clinician was able to pick the pieces of dressing off with her fingers.There were no adverse problems for the patient.It was discovered the clinician applied polymem max on a dry wound without moistening the dressing slightly prior to application, contrary to ifu guidance for appropriate use of the device.

• Brand Name: PolyMem MAX Silver Non-Adhesive Pad Dressing
• Common Device Name: PolyMem Silver MAX
• 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 ; +1(817)900-1306
• MDR Report Key: 50092605
• Report Number: 1419520-2026-00011
• Device Sequence Number: 13212396
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 08526A1
• 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: 07/20/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• 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: Unknown