Study: NCT01866475

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Notes: pain, without other symptoms, is a known and expected adverse event associated with intraosseous access and infusion
Frequency: 26 affected / 40 at risk

Adverse event: swelling - IO site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vasovagal response
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: pain - various focus points
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: left arm, 1st degree burn
Frequency: 1 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: emesis / nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Fractured tooth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: nausea / upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Notes: pain, without other symptoms, is a known and expected adverse event associated with intraosseous access and infusion
Frequency: 2 affected / 3 at risk

Adverse event: swelling - IO site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Elevated White Blood Cells
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: elevated white blood cells and elevated neutrophils
Frequency: 1 affected / 84 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 84 at risk

Adverse event: Imprint EZ-IO
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Imprint of EZ-IO catheter hub on the skin surface
Frequency: 1 affected / 84 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Notes: pain, without other symptoms, is a known and expected adverse event associated with intraosseous access and infusion
Frequency: 75 affected / 84 at risk

Adverse event: pain - referred pain, distal tibia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Referred pain to distal tibia from right IO site
Frequency: 1 affected / 84 at risk

Adverse event: Scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: scar matches demarcation of device hub, hypopigmented at insertion sites
Frequency: 1 affected / 84 at risk

Adverse event: soreness - arm left
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: swelling - IO site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 84 at risk

Adverse event: Vasovagal response
Serious: no
Organ System: General disorders
Frequency: 2 affected / 84 at risk

Adverse event: pain- left heel foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: soreness- left knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: pain - various focus points
Serious: no
Organ System: General disorders
Frequency: 9 affected / 84 at risk

Adverse event: Skin - local allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: superficial phlebitis
Frequency: 2 affected / 84 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: erythema - knee
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 84 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: junctional heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: nausea / upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: swelling - knee posterior
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 84 at risk