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

Model Number	1
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Anaphylactoid / Anaphylaxis (2218); Urticaria (2278)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a patient that initially presented with an allergic type reaction that was localized to the ulcer area after the first application of puraply am and subsequently developed into a generalized body rash, hives, itching, and erythema after his second application.The patient did not develop an immediate reaction to puraply am, but instead became sensitized and developed a systemic response after reapplication.This event is considered moderate in severity because the reaction was not limited to the local wound/periwound area and was generalized, affecting the whole body with hives.No physical impairment or permanent injury resulted.Other than the allergic reaction, no other complications or symptoms (e.G.Deterioration of ulcer, infection) occurred.Puraply am was removed as part of the intervention.The condition resolved following removal of the product and treatment of the allergic type reaction consisting of oral benadryl and one course of a medrol dose pak (oral steroid commonly used to treat conditions such as allergic reactions and inflammation).The patient is currently doing well, puraply am has been discontinued, and the ulcer is progressing.The treating physician states that the reported event is related to puraply am.The reported event is not expected, as the antimicrobial component of the product, polyhexamethylene biguanide (phmb) has been shown to carry only a slight allergic risk and remains an uncommon contact allergen.Furthermore, as per the physician, the patient was not allergic to porcine, and puraply am is made out of porcine tissue.
Event or Problem Description
On (b)(6) 2017 it was reported that a patient experienced an adverse event after a second application of puraply antimicrobial (2 cm x 4 cm unit size).Per the information initially provided by the vascular services manager for (b)(6) center submitted on june 22, 2017 on behalf of the treating physician, the patient had hives, redness and itching on the treated leg which was witnessed on (b)(6) 2017.On july 11 the treating physician provided additional information.Per the treating physician, the patient presented with a chronic venous leg ulcer on the left lower extremity that had been present for some time.The patient underwent a previous procedure for a perforated vein and had been undergoing wound care for the ulcer which had consisted of debridement, moist dressings, and layered compression therapy.The patient had his first application of puraply am, along with secondary dressings consisting of adaptic and layered compression, on (b)(6) 2017.The treating physician reported the type of secondary dressings were not a new treatment for the patient.The patient returned for his follow up visit on (b)(6)2017 with complaints of itching and burning around the site of the ulcer.The treating physician reported the ulcer had not deteriorated and had mild erythema and irritation, but he felt the appearance of the ulcer and the symptoms of itching and burning were expected for an ulcer of this etiology.For this reason, the treating physician stated it did not deter him from applying a second puraply am on the same day ((b)(6) 2017).He also applied the same secondary dressings.The treating physician reported 1-2 days after the second application, the patient presented to the emergency room, where he was found to have a generalized body rash which worsened around the area of the ulcer and around the ulcer edge.The puraply am as well as all dressings were removed in the er, and the patient was given oral benadryl and a medrol dose pak.The patient was not hospitalized and was discharged home.The patient did improve rapidly and symptoms were almost resolved within 4-5 days of receiving the medication with complete resolution in about two weeks.The treating physician stated that the ulcer did not worsen or deteriorate on his follow up visit on (b)(6) 2017.He denied recurrence of symptoms and the patient is doing well and the ulcer is improving.Puraply am was not reapplied on this patient.The treating physician has made an assessment that the reported allergic type reaction (generalized body rash, hives, redness, and itching) was related to puraply am.He reported the patient had no changes in any medications around that time, and also reported the patient did not eat anything that was different than usual.He also admitted the patient had a medical history of skin cancer on the neck, hypertension, deep venous thrombosis, and obesity, and denied any history of autoimmune disorders or cutaneous allergic disorders that he is aware of.The treating clinician reported an allergy list of sulfa, heparin, and penicillin and did not believe the patient was allergic to porcine, as he eats pork.
Event or Problem Description
Correction of udi number on original report and addition of event codes.
Additional Manufacturer Narrative
Incorrect udi documentation on original report.This amendment is udi # correction and addition of event codes.(b)(4).

• 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: 6712880
• Report Number: 1221816-2017-00001
• Device Sequence Number: 1039977
• Product Code: FRO
• UDI-Device Identifier: 00618474000039
• UDI-Public: (01)00618474000039(10)AM170411.1.1B(17)2019-02-22
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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: 02/22/2019
• Device Model Number: 1
• Device Lot Number: AM170411.1.1B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 04/06/2018
• 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: Required Intervention