MAUDE Adverse Event Report: ORGANOGENESIS INC. PURAPLY ANTIMICROBIAL WOUND MATRIX

Model Number	515-014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although this event has been assessed by the treating clinician and organogenesis as probably unrelated to the use of puraply am, organogenesis has decided to submit this mdr as a conservative measure due to the moderate severity of the infection which resulted in hospitalization and intervention with iv antibiotics.This event did not result in death and was not life threatening.The event is resolved and no permanent damage to body structure or permanent impairment of function has occured as a result of the infection.
Event or Problem Description
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.

• Brand Name: PURAPLY ANTIMICROBIAL WOUND MATRIX
• Common Device Name: PURAPLY ANTIMICROBIAL WOUND MATRIX
• Manufacturer (Section D): ORGANOGENESIS INC.; 150 dan road; canton MA 02021
• MDR Report Key: 7692101
• Report Number: 1221816-2018-00003
• Device Sequence Number: 2771437
• Product Code: FRO
• UDI-Device Identifier: 00618474000084
• UDI-Public: (01)00618474000084(10)AM171211.1.2.D(17)2019-10-20
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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 Expiration Date: 10/20/2019
• Device Model Number: 515-014
• Device Lot Number: AM171211.1.2.D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR