Study: NCT03323736

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 2 affected / 68 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 68 at risk

Adverse event: Velopharyngeal Insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 68 at risk

Adverse event: Occluded Tube
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 2 events for 2 OR subjects and 6 events for 6 Pivotal subjects considered potentially related to device or procedure. All other Occluded Tube events considered not related to device, drug or procedure.
Frequency: 13 affected / 68 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event for 1 OR subject considered potentially related to procedure. All other Otorrhea events not related to device, drug or procedure.
Frequency: 19 affected / 68 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event for 1 Office Lead-In subject and 1 event for 1 Pivotal subject considered related to procedure. All other Ear Pain events considered not related to device, drug or procedure.
Frequency: 6 affected / 68 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 13 affected / 68 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 9 affected / 68 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 68 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 3 affected / 68 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 6 affected / 68 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 6 affected / 68 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 68 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 2 affected / 68 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 68 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 2 affected / 68 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 3 affected / 68 at risk

Adverse event: Inadequate Anesthesia
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Inadequate anesthesia determined after completion of Tymbion iontophoresis procedure and prior to attempting tube placement. Potentially related to device, drug or procedure. This event type is not applicable to OR procedures.
Frequency: 4 affected / 47 at risk

Adverse event: Occluded Tube
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 2 events for 2 OR subjects and 6 events for 6 Pivotal subjects considered potentially related to device or procedure. All other Occluded Tube events considered not related to device, drug or procedure.
Frequency: 5 affected / 47 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event for 1 OR subject considered potentially related to procedure. All other Otorrhea events not related to device, drug or procedure.
Frequency: 7 affected / 47 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event for 1 Office Lead-In subject and 1 event for 1 Pivotal subject considered related to procedure. All other Ear Pain events considered not related to device, drug or procedure.
Frequency: 9 affected / 47 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 11 affected / 47 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 3 affected / 47 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 47 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 47 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 47 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 47 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 3 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Not related to device, drug or procedure
Frequency: 3 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 4 affected / 47 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 3 affected / 47 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 222 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 222 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 1 affected / 222 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 2 affected / 222 at risk

Adverse event: Inadequate Anesthesia
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Inadequate anesthesia determined after completion of Tymbion iontophoresis procedure and prior to attempting tube placement. Potentially related to device, drug or procedure. This event type is not applicable to OR procedures.
Frequency: 8 affected / 222 at risk

Adverse event: Occluded Tube
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 2 events for 2 OR subjects and 6 events for 6 Pivotal subjects considered potentially related to device or procedure. All other Occluded Tube events considered not related to device, drug or procedure.
Frequency: 51 affected / 222 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event for 1 OR subject considered potentially related to procedure. All other Otorrhea events not related to device, drug or procedure.
Frequency: 60 affected / 222 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 event for 1 Office Lead-In subject and 1 event for 1 Pivotal subject considered related to procedure. All other Ear Pain events considered not related to device, drug or procedure.
Frequency: 29 affected / 222 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 61 affected / 222 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 18 affected / 222 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 16 affected / 222 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 17 affected / 222 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 12 affected / 222 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 10 affected / 222 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 2 affected / 222 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 15 affected / 222 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Not related to device, drug or procedure
Frequency: 7 affected / 222 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Not related to device, drug or procedure
Frequency: 6 affected / 222 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 6 affected / 222 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device, drug or procedure
Frequency: 6 affected / 222 at risk