Study: NCT03903692

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient fell due to pre-existing condition of neuropathy condition not related to her wound. Found not to be related to the products in the study.
Frequency: 1 affected / 23 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This SAE was not related to the study products and relevant medical history to this SAE was diabetes, heart burn, deep vein thrombosis (DVT), irregular heartbeat, and hypertension. subject completed final visit.
Frequency: 1 affected / 23 at risk

Adverse event: Adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin conditions found not to be related to study products.
Frequency: 3 affected / 23 at risk

Adverse event: Adverse event
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Events were found not to be related to study products.
Frequency: 2 affected / 23 at risk

Adverse event: Adverse event
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation. not to be related to study products.
Frequency: 8 affected / 23 at risk

Adverse event: Adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Found to be related to CoFlex product, not the investigational product.
Frequency: 1 affected / 23 at risk

Adverse event: Adverse event
Serious: no
Organ System: Infections and infestations
Notes: Suspected infections were found not to be related to study products.
Frequency: 1 affected / 23 at risk

Adverse event: Adverse event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary congestion with pleural effusion. Found not to be related to study products.
Frequency: 1 affected / 23 at risk

Adverse event: All-Cause Mortality
Serious: yes
Organ System: Renal and urinary disorders
Notes: Death - The unexpected adverse event was end organ failure and not related to study products.
Frequency: 1 affected / 20 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was admitted to the hospital due to rectal bleeding. Found not to be related to study products.
Frequency: 1 affected / 20 at risk

Adverse event: Adverse event
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation. not to be related to study products.
Frequency: 5 affected / 20 at risk

Adverse event: Adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Found to be related to CoFlex product, not the investigational product.
Frequency: 1 affected / 20 at risk

Adverse event: Adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ulcers, found not to be related to study products.
Frequency: 3 affected / 20 at risk

Adverse event: Adverse event
Serious: no
Organ System: Infections and infestations
Notes: Suspected infections were found not to be related to study products.
Frequency: 2 affected / 20 at risk

Adverse event: Adverse event
Serious: no
Organ System: Renal and urinary disorders
Notes: Venaseal and end of organ failure. Found not to be related to study products.
Frequency: 1 affected / 20 at risk