Study: NCT03333941

Adverse event: Non-healing Third Degree Burn R/T Caffeine Intake Capillary Constriction LL Arm Req. Add'l Grafting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Pseudomonas Infection of Grafts
Serious: yes
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss Due to Immobility Over Posteriorly Located Pressure Bearing Surfaces Requiring Re-graftin
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Wound Cultures Positive for Staph Aureus Requiring Surgical Intervention
Serious: yes
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Area of Flap Dehisced Requiring Inset of Flap Under Anesthesia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Inpatient Surgery for Excision and Scar Release
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss with Wound Infection
Serious: yes
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Wound Infection Pseudomonas Aeruginosa
Serious: yes
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Failure with Wound Infection
Serious: yes
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: 100% Graft Loss Right Leg
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 76 at risk

Adverse event: Colonic Perforation and Evisceration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 76 at risk

Adverse event: Aortic Thrombus
Serious: yes
Organ System: Cardiac disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 76 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 76 at risk

Adverse event: Stage 3 Necrotic Pressure Ulcer Right Heel
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: NON-STUDY AREA
Frequency: 1 affected / 76 at risk

Adverse event: Ecoli Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Multi-Organ Dysfunction with Acute Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cardiac Arrest with Return of Spontaneous Circulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Acute Respiratory Failure with Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Acute Blood Loss Anemia Secondary to Epistaxis, Gastric Bleeding Evidenced by Wheezing & Edema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pulselessness Due to Progression of Metastatic State 4 Lung Cancer
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Ventilator Associated Pneumonia-Pseudomonas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Symptomatic Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Worsening Hyperglycemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Sepsis - Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hospitalized for Hyperglycemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Death due to Drug Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Ulnar Neuropathy of Left Upper Extremity
Serious: no
Organ System: Vascular disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Worsening of Previous Medical History of Neuropathic Pain
Serious: no
Organ System: Vascular disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Increase in Past Medical History of Acute Pain due to Burn Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Melting Graft Wound Syndrome
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Slowly Healing Donor Sites at Distal Bilateral Lower Extremities Requring Excision
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Melt Bilateral Posterior Lower Extremities
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Fall with Body Laceration of Study Treatment Area
Serious: no
Organ System: General disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Burn Injury Resulted in Exposure of Implantable Defribrillator
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Failure 275 sq cm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Failure Approximately 275 Sq Cm.
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Bleeding to Surgical Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Failure 150 sq cm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Necrosis Left Knee
Serious: no
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Failure 9 sq cm due to Knee Immobilizer
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Failed Graft Requiring Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Hypergranulation Tissue Left Torso
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Hypergranulation Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Eschar Left Elbow
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Hypergranulation Tissue Knees and Calf
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Hypergranulation Tissue Feet
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss Right Breast
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss to Right Thigh
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss Abdomen
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss Left Breast
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss (R Buttock)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Suspected Wound Infection (Right Buttock)
Serious: no
Organ System: Infections and infestations
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Hypertrophic Scar to Back of Right Knee
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: RECELL
Frequency: 1 affected / 76 at risk

Adverse event: Burn Site Pain
Serious: no
Organ System: General disorders
Notes: RECELL
Frequency: 7 affected / 76 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 2 affected / 76 at risk

Adverse event: Burn Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RECELL
Frequency: 2 affected / 76 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: RECELL Treated Donor Site
Frequency: 1 affected / 76 at risk

Adverse event: Decreased Range of Motion of Bilateral Lower Extremities and Hands
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-RECELL Treated Donor Site
Frequency: 1 affected / 76 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Non-RECELL Treated Donor Site
Frequency: 1 affected / 76 at risk

Adverse event: Crusting Wounds at Right Ear, Scalp and Forehead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-RECELL Treated Donor Site
Frequency: 1 affected / 76 at risk

Adverse event: Increased Delirium
Serious: no
Organ System: Psychiatric disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Thrombocytopenia (Increased from Prior Medical History)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Growth in Right Eyelid (Unknown Type)
Serious: no
Organ System: Eye disorders
Notes: Non-Study Area
Frequency: 1 affected / 76 at risk

Adverse event: Right Eye Ectropian
Serious: no
Organ System: Eye disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss Right Forearm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Graft Loss (L Buttock)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Suspected Wound Infection (Left Buttock)
Serious: no
Organ System: Infections and infestations
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Hypertrophic Scarring of Left Buttock
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-study Area
Frequency: 3 affected / 76 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Non-study Area
Frequency: 1 affected / 76 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Bilateral Lower Extremity Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Acute Blood Loss Due to Postoperative Anemia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 76 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 76 at risk

Adverse event: Low Arterial Blood Pressure Postoperatively
Serious: no
Organ System: Investigations
Frequency: 1 affected / 76 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Bacteremia Secondary to Exposed ICD Generator
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonia klebsiella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Suspected Urinary Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: MRSA Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 76 at risk

Adverse event: Burn Site Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 76 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk