Study: NCT00558246

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 79 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 79 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at application site assessed as not related to device but to procedure.
Frequency: 3 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was assessed as not related to device but to procedure.
Frequency: 3 affected / 79 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Events assessed as not related to device but to procedure.
Frequency: 3 affected / 79 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events assessed not related device but to procedure.
Frequency: 1 affected / 79 at risk

Adverse event: Procedure Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 79 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 79 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 79 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at application site assessed as not related to device but to procedure.
Frequency: 2 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was assessed as not related to device but to procedure.
Frequency: 2 affected / 78 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Events assessed as not related to device but to procedure.
Frequency: 1 affected / 79 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events assessed not related device but to procedure.
Frequency: 1 affected / 79 at risk

Adverse event: Procedure Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 79 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 79 at risk

Adverse event: Elective Brachioplasty
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject underwent planned bilateral brachioplasty for hanging skin. The event required hospitalisation for medical/surgical intervention. In the opinion of the Investigator, the event was classified as not related to sutures or Prineo.
Frequency: 1 affected / 79 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Following treatment, patient experienced postoperative sepsis and was hospitalized. Patient required surgical reintervention and was treated with antibiotics. No action was taken with respect to the study.
Frequency: 1 affected / 79 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 79 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 79 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itchiness at application site assessed as not related to device but to procedure.
Frequency: 5 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea was assessed as not related to device but to procedure.
Frequency: 12 affected / 79 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Events assessed as not related to device but to procedure.
Frequency: 9 affected / 79 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Events assessed not related device but to procedure.
Frequency: 4 affected / 79 at risk

Adverse event: Procedure Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 79 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 79 at risk