Study: NCT00396877

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 436 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 436 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 436 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 436 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 436 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 436 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 436 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 436 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 436 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 436 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 436 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 436 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 436 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 436 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 436 at risk

Adverse event: Enterobacter sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Enterococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Meningitis pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Candida sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Gastroenteritis caliciviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 436 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Post procedural cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Viral diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Wound abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 436 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Hypogammaglobulinaemia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 436 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 436 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 436 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 436 at risk

Adverse event: Food intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 436 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 436 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 436 at risk

Adverse event: Hypoglycaemic seizure
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 436 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 436 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 436 at risk

Adverse event: Convulsions local
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 436 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 436 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 436 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 436 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 436 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 436 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 436 at risk

Adverse event: Pericardial haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 436 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Low cardiac output syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 436 at risk

Adverse event: Nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Tricuspid valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 436 at risk

Adverse event: Ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 436 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 436 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 436 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 436 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 436 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 436 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 436 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 436 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 436 at risk

Adverse event: Pulmonary artery stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 436 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Diaphragmatic paralysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Laryngeal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Pulmonary vein stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Chylothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Mediastinal haematoma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Mediastinal haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Tracheal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Vocal cord thickening
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 436 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 436 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 436 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 436 at risk

Adverse event: Duodenal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 436 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pneumatosis intestinalis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 436 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 436 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 436 at risk

Adverse event: Vesicoureteric reflux
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 436 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 436 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 436 at risk

Adverse event: Puncture site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 436 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Feeling abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Vessel puncture site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 436 at risk

Adverse event: Blood urine present
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 436 at risk

Adverse event: Bronchial aspiration procedure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 436 at risk

Adverse event: Oxygen saturation increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 436 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 436 at risk

Adverse event: Pulmonary arterial pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 436 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 436 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 436 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 436 at risk

Adverse event: Shunt stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 436 at risk

Adverse event: Procedural site reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Graft thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Postoperative respiratory distress
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 436 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Shunt malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 436 at risk

Adverse event: Shunt occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Suture rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 436 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 436 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 436 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 436 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 436 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 464 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 464 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 464 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 464 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 464 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 464 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 464 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 464 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 464 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 464 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 464 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 464 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 464 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 464 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 464 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 464 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 464 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 464 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 464 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 464 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 464 at risk

Adverse event: Nosocomial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Fungal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Viral rash
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 464 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Enterobacter sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Haemophilus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Impetigo
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Klebsiella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Mediastinal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Meningitis pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Pneumonia escherichia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 464 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 464 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 464 at risk

Adverse event: Deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 464 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 464 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 464 at risk

Adverse event: Food intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 464 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hypoproteinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 464 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 464 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 464 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 464 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 464 at risk

Adverse event: Vocal cord paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 464 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 464 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 464 at risk

Adverse event: Poor sucking reflex
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Vocal cord paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Clonic convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hypoglycaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Phrenic nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Subarachnoid haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 464 at risk

Adverse event: Middle ear inflammation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 464 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 464 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 464 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 464 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 464 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 464 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 464 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 464 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 464 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 464 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 464 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cardiac pseudoaneurysm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dilatation ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pericardial haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 464 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 464 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 464 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 464 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 464 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 464 at risk

Adverse event: Vascular stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 464 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 464 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 464 at risk

Adverse event: Pulmonary artery stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 464 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 464 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 464 at risk

Adverse event: Diaphragmatic paralysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Laryngeal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pulmonary vein stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Upper respiratory tract congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Bronchostenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Chylothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pulmonary vein occlusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Respiratory fatigue
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Tracheomalacia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 464 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 464 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 464 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 464 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 464 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 464 at risk

Adverse event: Enterocolitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 464 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Post-tussive vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 464 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dermatitis diaper
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 464 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 464 at risk

Adverse event: Rash papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 464 at risk

Adverse event: Subcutaneous emphysema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 464 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 464 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 464 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 464 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 464 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pulmonary artery stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 464 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 464 at risk

Adverse event: Puncture site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 464 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 464 at risk

Adverse event: Catheter site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 464 at risk

Adverse event: Irritability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 464 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 464 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 464 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 464 at risk

Adverse event: Pulmonary arterial pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 464 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 464 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 464 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 464 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 464 at risk

Adverse event: Post procedural fever
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Shunt stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 464 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Suture related complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Pneumothorax traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Post vaccination syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Procedural site reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Shunt blood flow excessive
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 464 at risk

Adverse event: Anorectal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 464 at risk

Adverse event: Cardiovascular event prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 464 at risk

Adverse event: Ureteroneocystostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 464 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 464 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 464 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 464 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 464 at risk