PolyMem MAX SilverRecalls & reported problems
Ferris Mfg. Corp. · 8" x 8" MAX Silver Non Adhesive Pad Dressing · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10735471010889), received between Sep 2, 2025 and Jul 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Material Disintegration1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Improper or Incorrect Procedure or Method
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092605 ↗MalfunctionSep 2, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED A PATIENT HAS A LARGE PLANTAR FOOT WOUND AND 24 HOURS POST APPLICATION, THE DRESSING DISINTEGRATED IN THE WOUND.
Patient problems: Insufficient Information
MAUDE report 22930931 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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