Study: NCT03632954

Adverse event: inpatient wound management
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: abdominal pain/septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: discharge at device application site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: urinary tract infection/sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: accidental fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: shortness of breath/cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: scheduled surgery and hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: bleeding at wound site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: hematoma at device application site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: increase in wound size
Serious: no
Organ System: General disorders
Frequency: 6 affected / 37 at risk

Adverse event: inflammation at device application site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: near syncope episode
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: pain at application site, discharge at application site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: pain at device application site (excessive or exacerbated)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: cellulitis at device application site
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: cellulitis, leg
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: osteomyelitis at device application site
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 37 at risk

Adverse event: Skin maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: small maculopapular rash (possible reaction to complex wound dressing)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Wound necrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 37 at risk