Study: NCT00393887

Adverse event: Hematoma requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Notes: unrelated to the device
Frequency: 1 affected / 45 at risk

Adverse event: Urinary tract infection (UTI) requiring hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Notes: unrelated to the device
Frequency: 1 affected / 45 at risk

Adverse event: MI resulting in death
Serious: yes
Organ System: Cardiac disorders
Notes: unrelated to the device
Frequency: 1 affected / 45 at risk

Adverse event: Scrotal hematoma requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Notes: unrelated to the device
Frequency: 1 affected / 45 at risk

Adverse event: Bradycardia during hernia repair
Serious: yes
Organ System: Cardiac disorders
Notes: unrelated to the device
Frequency: 1 affected / 45 at risk

Adverse event: Right inguinal pain, inflammation, and tenderness
Serious: yes
Organ System: Infections and infestations
Notes: Requiring hospitalization - possibly related to the device
Frequency: 1 affected / 45 at risk

Adverse event: Left groin pain and scrotal swelling
Serious: yes
Organ System: Infections and infestations
Notes: Requiring hospitalization - possibly related to the device
Frequency: 1 affected / 45 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 45 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 45 at risk

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 45 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: Testicular problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 45 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 45 at risk

Adverse event: Incisional pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 45 at risk

Adverse event: Procedural site reaction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 45 at risk

Adverse event: Diverticulitis and prostatitis requiring hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: unrelated to the device
Frequency: 1 affected / 50 at risk

Adverse event: Substantial bleeding with central-line placement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: unrelated to the device
Frequency: 1 affected / 50 at risk

Adverse event: Motorcycle accident resulting in death
Serious: yes
Organ System: General disorders
Notes: unrelated to the device
Frequency: 1 affected / 50 at risk

Adverse event: Severe pain requiring hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: unrelated to the device
Frequency: 1 affected / 50 at risk

Adverse event: Urinary retention requiring overnight observation
Serious: yes
Organ System: Renal and urinary disorders
Notes: unrelated to the device
Frequency: 1 affected / 50 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 50 at risk

Adverse event: Testicular problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 50 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Incisional pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 50 at risk