PuraPly™ Antimicrobial Wound Matrix 515-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618474000084), received between Jul 16, 2018 and Jul 16, 2018 — classified as 1 injury.

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 18, 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.

• InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, (B)(6) YEAR OLD PATIENT, (B)(6), RECEIVED APPLICATION OF PURAPLY AM ON LEFT LOWER EXTREMITY FOR CHRONIC VENOUS ULCERATION THAT HAS BEEN PRESENT SINCE (B)(6) 2017. THE PATIENT WAS DEBRIDED AS USUAL AND THE WOUND BED WAS 85% FIBRINOUS SLOUGH AND 15% GRANULATION TISSUE. PURAPLY AM WAS APPLIED AND COVERED WITH ADHERENT DRESSING, GAUZE AND COMPRESSION WRAP. ON (B)(6) 2018, THE PATIENT WENT TO THE EMERGENCY ROOM ON HIS OWN ACCORD DUE TO SYMPTOMS OF FEVERS AND CHILLS AND WAS ADMITTED FOR A LEFT LOWER EXTREMITY CELLULITIS WITH INCREASED REDNESS AND SWELLING. THE PATIENT WAS TREATED BY AN INFECTIOUS DISEASE SPECIALIST WITH IV ANTIBIOTICS (VANCOMYCIN AND ZOSYN) AND LOCAL DRESSINGS CONSISTING OF NONADHERENT AND COMPRESSION AND WAS DISCHARGED ON (B)(6) 2018 ON ORAL ANTIBIOTICS (UNKNOWN NAME). NO SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT FOLLOWED UP AT THE WOUND CARE CENTER ON (B)(6) 2018 WITH IMPROVEMENTS IN THE WOUND BED WITH 40% GRANULAR TISSUE AND 60% FIBRINOUS SLOUGH. THERE WAS NO "DETERIATION" OF THE ULCERATION AND THE SYMPTOMS OF CELLULITIS HAD RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 7692101 ↗