Study: NCT02608463

Adverse event: Pre-Term Labor
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Start Date(s): 03/04/2017; 01/10/2017 End Date(s): 03/04/2017; 01/11/2017 4 - Unrelated to Study Device 5 - Emergency C-section
Frequency: 1 affected / 10 at risk

Adverse event: Incision Infection
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 03/04/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Surgery \& Wound Care
Frequency: 1 affected / 10 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 12/08/2016 End Date: 02/16/2017 4 - Unrelated to Study Device 5 - Antibiotic, cough syrup, admission to hospital
Frequency: 1 affected / 10 at risk

Adverse event: Drug withdrawal syndrome neonatal
Serious: yes
Organ System: Social circumstances
Notes: Start Date(s): 04/15/2017; 04/15/2017 End Date(s): 04/29/2017; 04/29/2017 4 - Unrelated to Study Device 5 - NICU Admission
Frequency: 1 affected / 10 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 04/20/2017 End Date: 04/22/2017 4 - Unrelated to Study Device 5 - NICU Admission
Frequency: 1 affected / 10 at risk

Adverse event: Transient Trachypnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Start Date: 04/20/2017 End Date: 04/22/2017
Frequency: 1 affected / 10 at risk

Adverse event: Pain Increase
Serious: no
Organ System: Nervous system disorders
Notes: Start Date(s): 10/27/2016; 12/01/2016; 11/17/2016; 12/22/2016; 02/16/2017; 11/17/2016; 07/13/2017; 12/01/2016; 12/01/2016; 04/06/201; 06/01/2017; 04/13/2017; 05/11/2017; 05/18/2017; 08/10/2017
Frequency: 8 affected / 10 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Start Date(s): 11/17/2016; 06/05/2017;02/13/2017; 04/27/2017; 11/03/2016;12/01/2016; 06/01/2017; 05/18/2017; 08/03/2017 4 - Unrelated to Study Device 3 - Resolved / Recovered
Frequency: 3 affected / 10 at risk

Adverse event: Anesthesia Difficulty
Serious: no
Organ System: Nervous system disorders
Notes: Start Date: 12/16/2016 End Date: 12/16/2016 4 - Unrelated to study device

1 - Recovered / Resolved
Frequency: 1 affected / 10 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 10/27/2016; 09/22/2016; 07/13/2017; 05/26/2017; 12/01/20160; 6/01/2017; 06/08/2017; 04/13/2017; 05/18/2017; 07/13/2017; 08/10/2017f 4 - Unrelated to study device 2 - recovering / resolving
Frequency: 4 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date(s): 01/26/2017; 12/22/2016 End Date(s): Ongoing 4 - Unrelated to study device 3 - Not recovered / resolved
Frequency: 2 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Start Date: 01/26/2017 End Date: Ongoing 4 - Unrelated to Study Device 3 - Not recovered / resolved
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Start Date: 02/23/2017 End Date: Ongoing 4 - Unrelated to study device 2 - Recovering / Resolving
Frequency: 1 affected / 10 at risk

Adverse event: Vision Changes
Serious: no
Organ System: Eye disorders
Notes: Start Date: 11/17/2016 End Date: 12/16/2016 4 - Unrelated to Study Device

1- Recovered / Resolved
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date(s): 02/23/2017; 11/03/2016; 11/17/2016; 08/31/2016; 02/16/2017; 12/01/2016; 02/26/2017; 04/27/2017; 06/29/2017; 08/10/2017 4- Unrelated to Study Device 5 - Recovered Resolved
Frequency: 3 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date(s): 02/23/2017; 12/01/2016; 02/26/2017; 04/27/2017 4 - Unrelated to study device

1 - Recovered / Resolved
Frequency: 2 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 08/25/2016; 11/03/2016; 02/16/2017; 10/17/2016; 08/31/2016; 12/01/2016; 04/06/2017; 02/23/2017; 04/13/2017; 06/08/2017; 06/15/2017; 04/27/2017; 08/10/2017 4- Unrelated to the study device

1 - resolved / recovered
Frequency: 3 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 08/25/2016; 08/23/2017 4 - Unrelated to the study device

1 - Recovered / Resolved
Frequency: 1 affected / 10 at risk

Adverse event: Hip Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 10/20/2016; 09/22/2016; 05/04/2017; 02/02/2017 4 - Unrelated to study device

1 - Recovered / Resolved
Frequency: 1 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 12/22/2016; 02/09/2017; 03/02/2017; 04/13/2017 4 - Unrelated to study device 3 - not recovered / resolved
Frequency: 1 affected / 10 at risk

Adverse event: Drowsiness or sedation
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date: 09/22/2016; 12/12/2016 4 - Unrelated to study device 6 - Unknown
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 09/22/2016 End Date: Ongoing 4 - Unrelated to study device 3 - not recovered / resolved
Frequency: 1 affected / 10 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Start Date: 10/27/2016; 02/23/2017 End Date: 10/27/2016; 03/16/2017 4 - Unrelated to study device

1 - recovered / resolved
Frequency: 2 affected / 10 at risk

Adverse event: Bilateral Feet Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Start Date: 10/24/2016 End Date: 10/27/2016 4 - Unrelated to study device

1 - recovered / resolved
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 02/16/2017; 10/17/2016 End Date: Ongoing 4 - Unrelated to study device 3 - not resolved / recovered
Frequency: 1 affected / 10 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date(s): 11/17/2016; 11/16/2016; 06/29/2017 4 - Unrelated to Study Device

1 - Recovered / resolved
Frequency: 1 affected / 10 at risk

Adverse event: Lip Tie
Serious: no
Organ System: General disorders
Notes: Start Date: 05/27/2017 End Date: Ongoing 4 - Unrelated to study device 4 - Residual effects present, not treated
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date: 10/26/2016; 12/21/2016; 06/29/2017; 04/13/2017 End Date: 11/02/2016; 12/28/2016; 06/29/2017; 05/24/2017 4 - Unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 10 at risk

Adverse event: Hemorrhoid
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date: 02/23/2017; 06/29/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered
Frequency: 2 affected / 10 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Tooth pain or Absess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date: 06/29/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered
Frequency: 1 affected / 10 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date: 04/27/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Start Date: 05/15/2017 End Date: 05/15/2017 4 - unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 10 at risk

Adverse event: Flank pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bilateral Hand Edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Numbness/tingling of bilateral hands
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Intubated, ventilator support, NICU
Frequency: 3 affected / 5 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Glucose given, NICU
Frequency: 1 affected / 5 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted to NICU, given ECHO
Frequency: 1 affected / 5 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Start date: 8/28/2019 End date: Ongoing 4 - Unrelated to Study Device 5- Intervention Phototherapy
Frequency: 1 affected / 5 at risk

Adverse event: Severe Retro-Micrognathia with Critical Airway
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5- Intervention Tracheotomy
Frequency: 1 affected / 5 at risk

Adverse event: Microtia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Intervention CT Scan \& Hearing evaluations
Frequency: 1 affected / 5 at risk

Adverse event: Microstomia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Placed gastrostomy tube \& CT Scan
Frequency: 1 affected / 5 at risk

Adverse event: Vertebral Anomalies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Chest X-Rays \& consulted orthopedics
Frequency: 1 affected / 5 at risk

Adverse event: Infection of Tracheotomy
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 09/24/2017 End Date: 9/30/2017 4 - Unrelated to Study Device 5 - antibiotics \& culture
Frequency: 1 affected / 5 at risk

Adverse event: Acinetobacter Infection of GT site
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 10/20/2017 End Date: 10/30/2017 4 - Unrelated to Study Device 5 - cultured infection \& antibiotics
Frequency: 1 affected / 5 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - placed gastrostomy tube \& speech therapy evaluation
Frequency: 1 affected / 5 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - discovered 5/4/2018 in clinical exam
Frequency: 1 affected / 5 at risk

Adverse event: Bilateral superior vena cava without bridging vein
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - admitted to NICU \& given ECHO
Frequency: 1 affected / 5 at risk

Adverse event: Shortened Femurs
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing
Frequency: 1 affected / 5 at risk

Adverse event: Bilateral Club Feet
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device

1 - discovered in clinical exam
Frequency: 1 affected / 5 at risk

Adverse event: Teratologic Hips
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 9/1/2017 End Date: Ongoing 4 - Unrelated to Study Device

1 - discovered by abdominal x-ray
Frequency: 1 affected / 5 at risk

Adverse event: Glossoptosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Start Date: 8/28/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - gastrostomy feeding tube
Frequency: 1 affected / 5 at risk

Adverse event: Medical neglect of child by caregiver
Serious: yes
Organ System: Social circumstances
Notes: Start Date: 11/21/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - DHS Report
Frequency: 1 affected / 5 at risk

Adverse event: Cardiopulmonary arrest with successful resuscitation
Serious: yes
Organ System: Cardiac disorders
Notes: Start Date: 12/06/2017 End Date: 12/06/2017 4 - Unrelated to Study Device 5 - CPR
Frequency: 2 affected / 5 at risk

Adverse event: Moraxella catarrhalis & HFLU Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 12/04/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Culture \& antibiotics
Frequency: 1 affected / 5 at risk

Adverse event: Hypochloraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Start Date: 11/26/2017 End Date: 12/06/2017 4 - Unrelated to Study Device 5 - IV fluids \& medications
Frequency: 1 affected / 5 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Notes: Start Date: 11/20/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - Medications for Sedation
Frequency: 1 affected / 5 at risk

Adverse event: Rhinovirus Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Start Date: 11/21/2017 End Date: Ongoing 4 - Unrelated to Study Device 5 - medication
Frequency: 1 affected / 5 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Start Date: 11/10/2016 End Date: 11/10/2016 4 - Unrelated to Study Device 5 - Emergency C-section
Frequency: 1 affected / 5 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Start Date: 11/10/2016 End Date: 11/12/2016 4 - Unrelated to Study Device 5 - NICU Admission
Frequency: 1 affected / 5 at risk

Adverse event: Pre-Term Labor
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Start Date(s): 03/04/2017; 01/10/2017 End Date(s): 03/04/2017; 01/11/2017 4 - Unrelated to Study Device 5 - Emergency C-section
Frequency: 1 affected / 5 at risk

Adverse event: Hellp Syndrome (Atypical)
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Start Date: 04/15/2017 End Date: 04/20/2017 4 - Unrelated to Study Device 5 - Hospital \& Nifedipine
Frequency: 1 affected / 5 at risk

Adverse event: Drug withdrawal syndrome neonatal
Serious: yes
Organ System: Social circumstances
Notes: Start Date(s): 04/15/2017; 04/15/2017 End Date(s): 04/29/2017; 04/29/2017 4 - Unrelated to Study Device 5 - NICU Admission
Frequency: 2 affected / 5 at risk

Adverse event: Metabolic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: seizure-like activity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5 at risk

Adverse event: Preterm Delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5 at risk

Adverse event: Patent foramen ovale
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 5 at risk

Adverse event: Severe Retro-Micrognathia with critical airway
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain Increase
Serious: no
Organ System: Nervous system disorders
Notes: Start Date(s): 10/27/2016; 12/01/2016; 11/17/2016; 12/22/2016; 02/16/2017; 11/17/2016; 07/13/2017; 12/01/2016; 12/01/2016; 04/06/201; 06/01/2017; 04/13/2017; 05/11/2017; 05/18/2017; 08/10/2017
Frequency: 3 affected / 5 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Start Date(s): 11/17/2016; 06/05/2017;02/13/2017; 04/27/2017; 11/03/2016;12/01/2016; 06/01/2017; 05/18/2017; 08/03/2017 4 - Unrelated to Study Device 3 - Resolved / Recovered
Frequency: 2 affected / 5 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 10/27/2016; 09/22/2016; 07/13/2017; 05/26/2017; 12/01/20160; 6/01/2017; 06/08/2017; 04/13/2017; 05/18/2017; 07/13/2017; 08/10/2017f 4 - Unrelated to study device 2 - recovering / resolving
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date(s): 02/23/2017; 11/03/2016; 11/17/2016; 08/31/2016; 02/16/2017; 12/01/2016; 02/26/2017; 04/27/2017; 06/29/2017; 08/10/2017 4- Unrelated to Study Device 5 - Recovered Resolved
Frequency: 2 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 08/25/2016; 11/03/2016; 02/16/2017; 10/17/2016; 08/31/2016; 12/01/2016; 04/06/2017; 02/23/2017; 04/13/2017; 06/08/2017; 06/15/2017; 04/27/2017; 08/10/2017 4- Unrelated to the study device

1 - resolved / recovered
Frequency: 2 affected / 5 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Start Date: 09/22/2016 End Date: Ongoing 4 - Unrelated to the study device 6 - Unknown
Frequency: 1 affected / 5 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Start Date: 10/09/2016 End Date: 11/10/2016 4 - Unrelated to the study device

1- Recovered / Resolved
Frequency: 1 affected / 5 at risk

Adverse event: Hip Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 10/20/2016; 09/22/2016; 05/04/2017; 02/02/2017 4 - Unrelated to study device

1 - Recovered / Resolved
Frequency: 1 affected / 5 at risk

Adverse event: Carpel Tunnel
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 10/20/2016 End Date: Ongoing 4 - Unrelated to Study Device 3 - Not recovered / resolved
Frequency: 1 affected / 5 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date(s): 12/22/2016; 02/09/2017; 03/02/2017; 04/13/2017 4 - Unrelated to study device 3 - not recovered / resolved
Frequency: 1 affected / 5 at risk

Adverse event: Hypervigilance
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date: 01/26/2017 End Date: Ongoing 4 - Unrelated to Study Device 3 - Not recovered / resolved
Frequency: 1 affected / 5 at risk

Adverse event: Drowsiness or sedation
Serious: no
Organ System: Psychiatric disorders
Notes: Start Date: 09/22/2016; 12/12/2016 4 - Unrelated to study device 6 - Unknown
Frequency: 1 affected / 5 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Right Ankle Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 05/08/2017 End Date: 06/22/2017 4 - Unrelated to study device

1 - recovered / resolved
Frequency: 1 affected / 5 at risk

Adverse event: Allergies
Serious: no
Organ System: Immune system disorders
Notes: Start Date(s): 08/31/2017; 04/27/2017 4 - Unrelated to study device

1 - recovered / resolved
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date: 10/26/2016; 12/21/2016; 06/29/2017; 04/13/2017 End Date: 11/02/2016; 12/28/2016; 06/29/2017; 05/24/2017 4 - Unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Start Date: 05/23/2017 End Date: 07/17/2017 4 - unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Start Date: 02/05/2017 End Date: 02/16/2017 4 - Unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Start Date: 02/10/2017 End Date 03/019/2017 4 - unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Start Date: 02/10/2017 End Date: 02/16/2017 4 - unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Skin Burning
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Start Date: 05/27/2017 End Date: 05/27/2017 4 - unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Mastitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Start Date: 05/26/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Start Date: 06/29/2017 End Date: Ongoing 4 - unrelated to study device 3 - not resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tooth pain or Absess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Start Date: 04/13/2017 End Date: 05/11/2017 4 - unrelated to study device

1 - resolved / recovered
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Premature labour
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diaper Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Low Lying Kidneys
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cellulitis at gastrostomy tube site
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk