PuraPly™ Antimicrobial Wound Matrix 515-008Recalls & reported problems
Organogenesis Inc. · PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618474000107), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Abscess1
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2017Improper or Incorrect Procedure or Method
ON (B)(6) 2017, THE PATIENT, PRESENTED TO THE CLINIC FOR HIS 9TH APPLICATION OF PURAPLY AM FOR A LEFT DIABETIC FOOT ULCER. THE TREATING CLINICIAN REPORTED THE PATIENT HAD A CHRONIC ULCERATION ON THE BASE OF THE 5TH METATARSAL DUE TO INCREASED PRESSURE CAUSED BY A SIGNIFICANT VALGUS DEFORMITY. HE STATED THE PATIENT PRESENTED ON (B)(6) 2017 WITH SOME COMPLAINTS OF PAIN AND SWELLING OF THE FOOT, BUT CLINICALLY DID NOT SHOW ANY SIGNS OF INFECTION (NEGATIVE FOR INCREASED DRAINAGE AND ODOR) AND WAS AFEBRILE. HE STATED HE ORDERED BLOOD WORK AND A CT SCAN, AND APPLIED PURAPLY AM. ON (B)(6) 2017 THE WOUND MEASURED 0.6 X 0.6 X 0.5 CM. AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION FROM THE CLINIC. TWO DAYS LATER, ON (B)(6) 2017, THE PATIENT DEVELOPED RIGOR AND CHILLS AND WENT TO THE HOSPITAL. THE PATIENT WAS FOUND TO HAVE A WHITE BLOOD CELL COUNT OF 25, AND WAS ADMITTED DUE TO AN ELEVATED WHITE COUNT. THE PATIENT DID NOT MEET THE SIRS CRITERIA AT ANY POINT DURING HOSPITALIZATION. THE PATIENT UNDERWENT DEBRIDEMENT IN THE OR AND DURING DEBRIDEMENT A FLUID COLLECTION WAS DISCOVERED IN THE BASE OF THE TARGET WOUND. THE PATIENT UNDERWENT INCISION AND DRAINAGE OF AN ABSCESS ON THE ULCERAT
Patient problems: Abscess; Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 7022748 ↗
Other Dressing, Wound, Drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 reports
- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- Medline DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page