Integra FWD301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780032472), received between Feb 10, 2022 and Feb 10, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072113); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A PHYSICIAN REPORTED THE PATIENT¿S PREVIOUS SURGEON TREATED THE PATIENT WITH FLOWABLE, BUT THE MATERIAL BECAME HARDENED, AND HAD TO BE REMOVED. THE PATIENT HAD ONGOING ISSUES EVER SINCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13505489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072113. One submission often covers many models, so check the product and lot details in each record.

• Z-1338-2019 · Mar 31, 2019 · Terminated
  Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgi