Study: NCT02921750

Adverse event: Fracture and hospitalisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Patient was fallen down and broke her left arm. Of Cause of that she needs an Operation and was in hospital.
Frequency: 1 affected / 124 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Erysipelas right leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: Renal and urinary disorders
Notes: Death unknown cause in the Aquacel group. Death due to acute renal failure in the Exufiber group
Frequency: 1 affected / 124 at risk

Adverse event: Local infection in study wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 124 at risk

Adverse event: Periwound skin irritation and blistering in study wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Flu infectious for 3 weeks
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Redness and irritation on Periwound Skin on left leg study ulcer .
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Swollen right ankle/foot.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Ulcer exacerbation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Stinging or burning while wearing study product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Local signs of infection at the target wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Eczema with tingling and pain on right foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pain in back due to fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Stasis dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 124 at risk

Adverse event: Pain of the wound unrelated to the dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 124 at risk

Adverse event: Gastric hemorrhage with hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: Renal and urinary disorders
Notes: Death unknown cause in the Aquacel group. Death due to acute renal failure in the Exufiber group
Frequency: 1 affected / 124 at risk

Adverse event: Pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Patient has increase pain, the wound status is going worse
Frequency: 1 affected / 124 at risk

Adverse event: Infection exacerbated COPD
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Erysipelas PDK, hospitalize
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Intensification of depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Intensification of depression symptoms in course of schizophrenia
Frequency: 1 affected / 124 at risk

Adverse event: Circulatory insufficiency with dehydration and dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Skin reaction around the wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Severe irritation around the wound. The dressing was done every 2 days with 2 Aquacel on the wound, contrary to the instructions of the protocol (a daily frequency with only 1 AQUACEL on the wound).
Frequency: 1 affected / 124 at risk

Adverse event: Scheduled hernia surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 124 at risk

Adverse event: Infection at study wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Wound infection right leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound infection right leg, and Increased redness in peri-wound skin.
Frequency: 1 affected / 124 at risk

Adverse event: Increased wound liquid
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The wound was covered with lots of blue-green-coloured slough, which Looks like pseudomonas
Frequency: 1 affected / 124 at risk

Adverse event: Skin blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Small skin blister and wound on the leg at the at area of dressing tape
Frequency: 1 affected / 124 at risk

Adverse event: Aggravation of known psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Strong itching in the marginal area of the wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infection of the target ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Fall at home with wound in the right leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Headache, tiredness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cough and inceased temperature
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Erysipel of nonstudy leg - left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Burning, erhema of the scalp.
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Aquacel dressing intolerance (burn and redness)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Increasing the ulcer with inflammatory reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: New ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 124 at risk