MAUDE Adverse Event Report: ORGANOGENESIS INC. PURAPLY MICRONIZED WOUND MATRIX; PURAPLY MZ

Model Number	515-061
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	02/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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 utilized.According to dr.(b)(6), three days postoperatively, the patient developed a seroma that subsequently became infected.She was hospitalized for four days due to the localized infection.There were no systemic signs of infection other than fever.During the admission, the patient underwent surgical debridement and washout of the surgical wound.During the procedure, the wound was irrigated and managed with the application of puraply am, which was packed and applied on the wound bed following debridement.Intraoperative cultures were negative for aerobic and anaerobic organisms with occasional white blood cells noted.Laboratory values included a white blood cell count of 8.52 and crp of 3.62.The patient was treated with intravenous antibiotics (zosyn, vancomycin, and daptomycin) and discharged after 4 days.The wound subsequently healed, and the patient has returned to full functional status.The event has resolved.According to dr.(b)(6), the event is related to puraply mz and noted this was his first time using the product.He indicated that seroma formation with infection is not a typical complication following lipoma resection at the knee.We are treating this report as an adverse event.Medical assessment: this event is moderate in severity.The patient required hospitalization and surgical intervention due to postoperative seroma formation and secondary infection.There was no indication of death, life-threatening injury, or permanent impairment.The event resolved, the wound healed, and the patient recovered with full return to function.While the physician considers the event related to puraply mz, the event is assessed as possibly related.As noted by dr.(b)(6), seroma formation with secondary infection is not a typical complication following lipoma resection in the knee region.Such complications are more commonly reported in breast and abdominal wall surgeries.1-4 however, seroma formation is a recognized postoperative complication- particularly in surgeries involving soft tissue excision or the creation of a potential dead space, as may occur in lipoma resections.1,5,6 seromas can increase the risk of secondary infection by serving as a medium for bacterial growth.1,2, 7-11 this supports the assessment the infection was not attributable to puraply mz.Furthermore, the product is terminally sterilized with gamma irradiation during manufacturing, and all sterilization processing specifications were met.The risks for seroma and subsequent infection are considered independent of puraply mz, and while a causal relationship cannot be ruled out, the event may be multifactorial and not soley attributable to puraply mz.No other complaints regarding this puraply mz lot have been reported to date.If additional information becomes available, this assessment will be re-evaluated and updated as necessary.Conclusion: opinion of the treating clinician.Severity: moderate.Relatedness: related.Expectedness: not expected.Medical assessment of the oi medical assessor.Severity: moderate.Relatedness: possibly related.Expectedness: not expected.

• Brand Name: PURAPLY MICRONIZED WOUND MATRIX
• Common Device Name: PURAPLY MZ
• Manufacturer (Section D): ORGANOGENESIS INC.; 150 dan road; canton MA 02021
• Manufacturer (Section G): ORGANOGENESIS INC.; 150 dan road; canton MA 02021
• Manufacturer Contact: christina nichols ; 85 dan road; canton, MA 02021 ; 7815776065
• MDR Report Key: 22078753
• Report Number: 1000148471-2025-00004
• Device Sequence Number: 8702609
• Product Code: KGN
• UDI-Device Identifier: 00618474000404
• UDI-Public: 00618474000404
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K220317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 515-061
• Device Lot Number: MZ240516.1.1B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female