MAUDE Adverse Event Report: ORGANOGENESIS INC. APLIGRAF

Lot Number	GS1901.29.03.1A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although this event has been assessed by the treating clinician as possibly related and by the medical assessment of the organogenesis assessor as probably unrelated to the use of apligraf, organogensis 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 resolved and no permanent damage to body structure or permanent impairment of function has occurred as a result of the infection.This event is expected, as infection is a common complication with chronic wounds.All sterility, bioburden, endotoxin and histology testing of the lot passed specification and there have been no other complaints from this lot of apligraf.
Event or Problem Description
On (b)(6) 2019, (b)(6) year old patient, mg, received application of apligraf on a wound originally caused by tripping on her walker on (b)(6) 2018.The original wound, a right lower extremity laceration was sutured in the er the same day, the patient was given a tetanus booster and ancef while in the er and discharged on a course of oral keflex.On (b)(6) 2018 the patient followed up in the wound care center and was found to have necrosis of the wound site and dehisced laceration.The patient was then treated weekly in the wound care center with serial debridements, dakin's solution and unna boot compression due to swelling.On (b)(6) 2019, the wound was improving with good granulation tissue and no signs of infection.On (b)(6) 2019, the wound was debrided and apligraf was applied on a portion of the wound since the wound was larger than the size of the apligraf.The apligraf was secured with steri-strips, covered with wound veil, saline moistened gauze and kling.On (b)(6)2019, the patient called the wound care center complaining of fevers and right lower extremity warmth and erythema and was told to go to the er.The patient was admitted with a diagnosis of right lower extremity cellulitis.The wound was cultured in three different locations, (1) over the apligraf, (2) on the portion of the wound that did not have the apligraf and (3) the wound bed where apligraf was applied (after removal).The patient was treated by an infectious disease doctor with iv vancomycin and zosyn during her admission.The apligraf was removed on (b)(6) 2019.The patient underwent a bedside incision and drainage and debridement by a general surgeon on (b)(6) 2019.The wound was treated locally with dakin's dressing throughout her hospitalization.The patient was discharged on (b)(6) 2019 on iv levaquin.The patient followed up at the wound care center on (b)(6) 2019 and the infection had completely resolved, and the wound was improving, with an area of some tunneling where the debridement was performed.The patient was still on iv levaquin and doing much better.

• Brand Name: APLIGRAF
• Common Device Name: APLIGRAF
• Manufacturer (Section D): ORGANOGENESIS INC.; 150 dan road; canton MA 02021
• MDR Report Key: 8439432
• Report Number: 1221816-2019-00001
• Device Sequence Number: 1780489
• Product Code: PFC
• UDI-Device Identifier: 00618474000008
• UDI-Public: 00618474000008
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BP953200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2019
• Device Lot Number: GS1901.29.03.1A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/21/2019
• 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: 76 YR