PuraPly Micronized Wound Matrix (PuraPly MZ) 515-061Recalls & reported problems
Organogenesis Inc. · PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of less than or equal to 1000. The device is sterile and packaged in a vial sealed in a single pouch. · 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 00618474000404), received between May 23, 2025 and May 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Post Operative Wound Infection1
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT DESCRIPTION: PHYSICIAN USED PURAPLY MZ IN A SURGICAL WOUND, AND THAT SURGICAL WOUND FORMED A SEROMA AND SUBSEQUENTLY BECAME INFECTED. REPORT SUMMARY: THIS REPORT IS BASED ON INFORMATION PROVIDED BY (B)(4), DISTRIBUTOR REPRESENTATIVE, WHO RELAYED RESPONSES FROM DR.(B)(6) VIA EMAIL, AND ALL AVAILABLE DOCUMENTATION. DURING A GENERAL DISCUSSION REGARDING ORGANOGENESIS PRODUCTS, (B)(4), EXECUTIVE DIRECTOR, ORTHOPEDIC BIOLOGICS AT ORGANOGENESIS, WAS INFORMED OF AN EVENT INVOLVING THE USE OF PURAPLY MZ. THE EVENT INVOLVED POSTOPERATIVE SEROMA FORMATION AT THE SURGICAL SITE, WHICH SUBSEQUENTLY BECAME INFECTED AND NECESSITATED A RETURN TO THE OPERATING ROOM (OR) FOR DEBRIDEMENT AND WASHOUT. THE COMPLAINT ABOUT THE EVENT WAS NOT INITIATED AT THE REQUEST OF THE PHYSICIAN. THE PATIENT, RR, A 74-YEAR-OLD FEMALE WITH NO SIGNIFICANT MEDICAL OR SURGICAL HISTORY AND KNOWN ALLERGY TO CODEINE, UNDERWENT SURGICAL INCISION OF A 6 CM RIGHT LATERAL KNEE LIPOMA ON (B)(6) 2025. NO BONE OR TENDON EXPOSURE WAS NOTED DURING THE PROCEDURE. PURAPLY MZ (LOT # MZ240516.1.1B) WAS APPLIED TO THE TISSUE OF THE SURGICAL SITE AND SURGICAL INCISION TO MANAGE THE SURGICAL WOUND. NO OTHER WOUND CARE PRODUCTS WERE U
Patient problems: Post Operative Wound Infection; Seroma
MAUDE report 22078753 ↗
Other Wound Dressing With Animal-Derived Material(S) devices
- PriMatrix® 607-001-812Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM0505Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-880Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-440Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-125Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 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.
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