Study: NCT00557947

Adverse event: Wound dehiscence
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject experienced wound dehiscence due to an infection. No action taken regarding device. The event was not related to the sutures, possibly related to the DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as possibly related to sutures and DERMABOND PROTAPE and as definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as related to sutures, possibly related to DERMABOND PROTAPE, and definitely related to the procedure
Frequency: 1 affected / 83 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject experienced hematoma, infection and dehiscence following treatment. No action was taken with devices for the events. The hematoma was classified as possibly related to sutures and DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The subject experienced wound infection (DERMABOND PROTAPE side). No was action taken regarding the study device. The event was classified as not related to sutures, definitely related to DERMABOND PROTAPE, and possibly related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Pain (General Disorders)
Serious: no
Organ System: General disorders
Notes: Pain at application site.
Frequency: 16 affected / 83 at risk

Adverse event: Procedure Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject experienced infection and seroma. No action was taken with device. The infjection was assessed as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The subject experienced an infection and seroma. No action was taken regarding the study device for either device. The seroma was classified as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as possibly related to sutures and DERMABOND PROTAPE and as definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as related to sutures, possibly related to DERMABOND PROTAPE, and definitely related to the procedure
Frequency: 1 affected / 83 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject experienced hematoma, infection and dehiscence following treatment. No action was taken with devices for the events. The hematoma was classified as possibly related to sutures and DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Notes: The subject experienced necrosis (blood supply problem to breast reconstruction) requiring device removal.The event was classified as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to procedure
Frequency: 1 affected / 83 at risk

Adverse event: Pain (General Disorders)
Serious: no
Organ System: General disorders
Notes: Pain at application site.
Frequency: 16 affected / 83 at risk

Adverse event: Procedure Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 83 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject experienced wound dehiscence due to an infection. No action taken regarding device. The event was not related to the sutures, possibly related to the DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: The subject experienced an infection and seroma. There was no action taken regarding the study device, The infection was classified as not related to either the sutures or the DERMABOND PROTAPE, but was definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Seroma
Serious: yes
Organ System: Surgical and medical procedures
Notes: The subject experienced an infection and seroma. There was no action taken regarding the study device, The seroma was classified as not related to either the sutures or the DERMABOND PROTAPE but was definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject experienced wound necrosis requiring surgical treatment. No action required with respect to device. The event was classified as not related to INTRADRERMAL SUTURES or the DERMABOND PROTAPE, but was definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject experienced infection and seroma. No action was taken with device. The infjection was assessed as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The subject experienced an infection and seroma. No action was taken regarding the study device for either device. The seroma was classified as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Procedural Complication (requiring removal of skin flap) due to congestion of blood supply
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject required required removal of the flap due to congestion of blood supply.There was no action taken regarding study device. Te event was classified as not related to the suture OR DERMABOND ROTAPE, but definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Surgical and medical procedures
Notes: During surgery, the subject experienced fluid overload (fluid induced respiratory depression). No action was taken with study device. The event was classified as not related to sutures or DERMABOND PROTAPE, and definitely related to the procedure
Frequency: 1 affected / 83 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: The subject experienced hematoma and dehiscence. No action was taken with device with respect to hematoma. The event was no related to sutures or DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The subject experienced hematoma and dehiscence. No action was taken with device with respect to dehiscence. The event was no related to sutures or DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as possibly related to sutures and DERMABOND PROTAPE and as definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject experienced hematoma, infection and dehiscence following treatment. The infection was classified as related to sutures, possibly related to DERMABOND PROTAPE, and definitely related to the procedure
Frequency: 1 affected / 83 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Subject experienced hematoma, infection and dehiscence following treatment. No action was taken with devices for the events. The hematoma was classified as possibly related to sutures and DERMABOND PROTAPE, and definitely related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The subject experienced wound infection (DERMABOND PROTAPE side). No was action taken regarding the study device. The event was classified as not related to sutures, definitely related to DERMABOND PROTAPE, and possibly related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: The subject experienced arrhythmia (Tachycardia) and breast abscess. No action taken regarding the study device with respect to arrythmia. The event was classified as not related to sutures or DERMABOND PROTAPE, and possibly related to the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Notes: The subject experienced necrosis (blood supply problem to breast reconstruction) requiring device removal.The event was classified as possibly related to sutures, not related to DERMABOND PROTAPE, and definitely related to procedure
Frequency: 1 affected / 83 at risk

Adverse event: Pain (General Disorders)
Serious: no
Organ System: General disorders
Notes: Pain at application site.
Frequency: 19 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea experienced following surgery.
Frequency: 6 affected / 83 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Insomnia experienced following surgery.
Frequency: 5 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 83 at risk

Adverse event: Procedure Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 83 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 83 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Subject experienced chest pain. No action was taken with study device. The event was classified as not related to sutures, DERMABOND PROTAPE, or the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Metastic Breast Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: The subject died of metastatic breast cancer. In the opinion of the investigator, the event was classified as not related to either the study device/procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Breast Abcess
Serious: yes
Organ System: Infections and infestations
Notes: The subject experienced arrhythmia (Tachycardia) and breast abscess. No action taken regarding the study device with respect to abscess. The abscess was classified as not related to the sutures or DERMABOND PROTAPE, or the procedure.
Frequency: 1 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 83 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk