Study: NCT01383018

Adverse event: Device Infection
Serious: yes
Organ System: Infections and infestations
Notes: 13 Device Infections, 10 were device related, 5 were procedure related, 3 of these were related to both device and procedure. All events were resolved.
Frequency: 11 affected / 1380 at risk

Adverse event: Erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 6 Erosion, 6 were device related with 2 being determined to also be procedure related All events were resolved.
Frequency: 6 affected / 1380 at risk

Adverse event: Reservoir Herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 3 Reservoir Herniation, 2 were device related, 1 was procedure related. All events were resolved.
Frequency: 3 affected / 1380 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Notes: 2 Abscess, 2 were device related with 1 being determined to also be procedure related. All events were resolved.
Frequency: 2 affected / 1380 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 2 Hematoma events, 2 were procedure related, 1 was related to both device and procedure.
Frequency: 2 affected / 1380 at risk

Adverse event: Pain/Discomfort
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 Pain/Discomfort events, device related.
Frequency: 1 affected / 1380 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: 2 urinary retention events, 1 was procedure related and 1 was device related.
Frequency: 2 affected / 1380 at risk

Adverse event: Cardiac Event - Non-specific
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: 1 cellulitis event, procedure related.
Frequency: 1 affected / 1380 at risk

Adverse event: Cylinder Crossover
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 cylinder crossover event, device related
Frequency: 1 affected / 1380 at risk

Adverse event: Device Cylinder Aneruysm/Bulge
Serious: yes
Organ System: Product Issues
Notes: 1 device cylinder aneurysm/bulge, device related
Frequency: 1 affected / 1380 at risk

Adverse event: Edema - Scrotal
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 edema - scrotal event, procedure and device related.
Frequency: 1 affected / 1380 at risk

Adverse event: Extrusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 extrusion event, device and procedure related
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort - Penile
Serious: yes
Organ System: General disorders
Notes: 1 pain/discomfort-penile event, device and procedure related
Frequency: 1 affected / 1380 at risk

Adverse event: Perforation - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 perforation event, device related
Frequency: 1 affected / 1380 at risk

Adverse event: Peyronie's disease
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: 1 Peyronie's Disease event, device related
Frequency: 1 affected / 1380 at risk

Adverse event: Proximal Corporal Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 proximal corporal perforation event, procedure related
Frequency: 1 affected / 1380 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Notes: 1 pulmonary embolus event, procedure event
Frequency: 1 affected / 1380 at risk

Adverse event: Urethral obstruction
Serious: yes
Organ System: Product Issues
Notes: 1 urethral obstruction event, device related
Frequency: 1 affected / 1380 at risk

Adverse event: Would Dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 wound dehiscence event, procedure related
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Substernal Chest Pain
Serious: yes
Organ System: Cardiac disorders
Notes: The event was reported by the site as not procedure or device related which does not fit the definition of a reportable SADE or UADE per the protocol.
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Decreased Oxygen Saturation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1380 at risk

Adverse event: Device Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1380 at risk

Adverse event: Erosion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1380 at risk

Adverse event: Pain/Discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1380 at risk

Adverse event: Reservoir Herniation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1380 at risk

Adverse event: Superficial Wound Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1380 at risk

Adverse event: Device Cylinder Aneurysm/Bulge
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1380 at risk

Adverse event: Migration (pump)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Urethral Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1380 at risk

Adverse event: Extrusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1380 at risk

Adverse event: Malposition
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1380 at risk

Adverse event: Pain/Discomfort - Groin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Priapism
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Adhesion of the Pump/Scrotum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Allergic reaction/Hypersensitivity Reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Auto Inflation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Bladder neck obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1380 at risk

Adverse event: Device Placement Failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Edema - Penile
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1380 at risk

Adverse event: Fibrosis
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Fibrous Capsule Formation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Incorrect Size - Cylinders too Large
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Increased Blood Loss
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Inguinal Hernia Formation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort - Penile
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort With Erections
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Patient Dissatisfaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Perforation - Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Peyronie's disease
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Proximal Corporal Perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Urinary Tract Infection - UTI
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1380 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1380 at risk

Adverse event: Pain/Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Migration (Pump)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Migration (Pump)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort - Groin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1380 at risk

Adverse event: Pain/Discomfort - Testicular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Pain/Discomfort - Testicular
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1380 at risk

Adverse event: Other - Buckling of left cylinder led to left downward curvature
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Painful mass in right hemiscrotum
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Left distal tip migration with pain at tip of penis with intercourse
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Right cylinder protruding
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Pinching sensation around the resevoirs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Change in curvature of penis (increase in curvature)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Proximal cross over during IPP surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Incisional drainage
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Bilateral corporal aneurysm
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Proximal crossover
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1380 at risk

Adverse event: Other - Slight separation of penoscrotal wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1380 at risk