Study: NCT00501085

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 515 at risk

Adverse event: Band erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 515 at risk

Adverse event: Band removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 515 at risk

Adverse event: Band Slip
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 515 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 515 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Fibrous Band Obstruction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 515 at risk

Adverse event: Gastric Erosion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastric Leak
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastric prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastrointestinal Stomal Tumor
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastroesophageal Reflux Disease (GERD)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: LapBand Port Revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 515 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 515 at risk

Adverse event: Band Slip
Serious: no
Organ System: General disorders
Frequency: 4 affected / 515 at risk

Adverse event: Band too tight
Serious: no
Organ System: General disorders
Frequency: 9 affected / 515 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 515 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 515 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 515 at risk

Adverse event: Dilated Gastric Pouch
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 515 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 515 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 515 at risk

Adverse event: Flipped Port
Serious: no
Organ System: General disorders
Frequency: 6 affected / 515 at risk

Adverse event: Food Obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 515 at risk

Adverse event: Gastroesophageal Reflux Disease (GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 515 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 515 at risk

Adverse event: Increased Restriction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 515 at risk

Adverse event: Pain at port site
Serious: no
Organ System: General disorders
Frequency: 7 affected / 515 at risk

Adverse event: Port Tube Leaking
Serious: no
Organ System: General disorders
Frequency: 3 affected / 515 at risk

Adverse event: Unable to tolerate solids/liquids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 515 at risk

Adverse event: Vomiting/Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 515 at risk

Adverse event: Port Site Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 515 at risk