PuraPly™ Antimicrobial Wound Matrix 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00618474000039), received between Jul 13, 2017 and Apr 6, 2018 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PURAPLY AM APPLIED TO A WOUND (UNKNOWN LOCATION, UNKNOWN ETIOLOGY) ON (B)(6) 2017. AT THE TIME OF THE APPLICATION, THE WOUND PRESENTED WITH SOME ERYTHEMA, AND EXCESSIVE EXUDATE, BLEEDING, ACUTE SWELLING, AND/OR INFECTION CONTROLLED. THERE WAS NO INFECTION AND BONE/TENDON WAS NOT EXPOSED. THE WOUND WAS FREE OF DEBRIS AND NECROTIC TISSUE. PURAPLY AM WAS PLACED DRY AND THEN REHYDRATED AND IN CONTACT WITH THE WOUND BED, SECURED WITH STERI-STRIPS AND COVERED WITH MEPITEL. THE PATIENT WAS TOLD TO FOLLOW UP IN ONE WEEK. ON THE PATIENTS FOLLOW UP VISIT ON (B)(6) 2017, THERE WAS EXCESSIVE REDNESS NOTED AND CELLULITIS, WHICH WAS CULTURED AND RESULTS WERE STAPH A (B)(6). ADDITIONAL INFORMATION ABOUT THE WOUND, THE CURRENT STATUS OF THE PATIENT AND OUTCOME IS UNKNOWN. WHETHER ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED IS UNKNOWN AND WHETHER THE PRODUCT WAS REMOVED OR REAPPLIED IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7404772 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PURAPLY AM APPLIED TO A WOUND (UNKNOWN LOCATION, UNKNOWN ETIOLOGY) ON (B)(6) 2017. AT THE TIME OF THE APPLICATION, THE WOUND PRESENTED WITH SOME ERYTHEMA, BUT WAS NOT INFECTED AND BONE/TENDON WAS NOT EXPOSED. THE WOUND WAS FREE OF DEBRIS AND NECROTIC TISSUE. PURAPLY AM WAS PLACED DRY AND THEN REHYDRATED AND IN CONTACT WITH THE WOUND BED, COVERED WITH MEPITEL. THE PATIENT WAS TOLD TO FOLLOW UP IN ONE WEEK. ON THE PATIENTS FOLLOW UP VISIT ON (B)(6) 2017, INFECTION WAS NOTED AS PERI WOUND ERYTHEMA, INCREASE IN WOUND SIZE AND CULTURES REVEALING ENTEROBACTER SPECIES. ADDITIONAL INFORMATION ABOUT THE WOUND, THE CURRENT STATUS OF THE PATIENT AND OUTCOME IS UNKNOWN. WHETHER ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED IS UNKNOWN AND WHETHER THE PRODUCT WAS REMOVED OR REAPPLIED IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7404500 ↗
• InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem

  CORRECTION OF UDI NUMBER ON ORIGINAL REPORT AND ADDITION OF EVENT CODES.

  Patient problems: Anaphylactoid / Anaphylaxis; Burning Sensation; Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Rash; Urticaria

  MAUDE report 6712880 ↗