Study: NCT01425268

Adverse event: Hematoma, Breast
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post operative hematoma with return to the OR
Frequency: 1 affected / 99 at risk

Adverse event: Stroke, Mild
Serious: yes
Organ System: Nervous system disorders
Notes: Mild Stroke, Admitted Overnight
Frequency: 1 affected / 99 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Fever with low wbc associated with chemotherapy
Frequency: 1 affected / 99 at risk

Adverse event: Red breast syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Inflammation of the breast tissue
Frequency: 1 affected / 99 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Seroma with needle guided aspiration
Frequency: 1 affected / 99 at risk

Adverse event: Extrusion
Serious: yes
Organ System: General disorders
Notes: Device extrusion through skin
Frequency: 1 affected / 99 at risk

Adverse event: Hematoma, Chest VAP Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hematoma after removal of Venous Access Port
Frequency: 1 affected / 99 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Superficial Cellulitis of Breast
Frequency: 5 affected / 99 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Wound Infection at the Surgical Site
Frequency: 1 affected / 99 at risk

Adverse event: Delayed Wound Healing
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Delayed wound healing, tissue necrosis
Frequency: 2 affected / 99 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Dehiscence (Separation) of the Incision
Frequency: 1 affected / 99 at risk

Adverse event: Erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Erosion of the skin overlying the expander
Frequency: 1 affected / 99 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post operative pneumothorax
Frequency: 1 affected / 99 at risk

Adverse event: Deflation
Serious: yes
Organ System: General disorders
Notes: Deflation
Frequency: 1 affected / 99 at risk

Adverse event: Under-Expansion
Serious: yes
Organ System: General disorders
Notes: Under-Expansion
Frequency: 1 affected / 99 at risk

Adverse event: Over-Expansion
Serious: yes
Organ System: Product Issues
Notes: Over-Expansion
Frequency: 4 affected / 99 at risk

Adverse event: Exposure
Serious: yes
Organ System: General disorders
Notes: Exposed Tissue Expander
Frequency: 1 affected / 99 at risk

Adverse event: Muscle Disruption
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Disruption of Alloderm-Muscle Interface
Frequency: 1 affected / 99 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Subject Reported Pain
Frequency: 10 affected / 99 at risk

Adverse event: Delayed Wound Healing
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Delayed Wound Healing / Tissue Necrosis,
Frequency: 14 affected / 99 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Seroma, Breast
Frequency: 14 affected / 99 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Post Op Wound Infection / Cellulitis
Frequency: 8 affected / 99 at risk

Adverse event: Hematoma, Breast
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post operative hematoma with return to the OR
Frequency: 1 affected / 52 at risk

Adverse event: Extrusion
Serious: yes
Organ System: General disorders
Notes: Device extrusion through skin
Frequency: 1 affected / 52 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Superficial Cellulitis of Breast
Frequency: 2 affected / 52 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Wound Infection at the Surgical Site
Frequency: 2 affected / 52 at risk

Adverse event: Delayed Wound Healing
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Delayed wound healing, tissue necrosis
Frequency: 1 affected / 52 at risk

Adverse event: Deflation
Serious: yes
Organ System: General disorders
Notes: Deflation
Frequency: 1 affected / 52 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Subject Reported Pain
Frequency: 10 affected / 52 at risk

Adverse event: Delayed Wound Healing
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Delayed Wound Healing / Tissue Necrosis,
Frequency: 3 affected / 52 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Seroma, Breast
Frequency: 5 affected / 52 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Post Op Wound Infection / Cellulitis
Frequency: 4 affected / 52 at risk