MESH, SURGICAL, POLYMERIC
This device is manufactured by SOFRADIM PRODUCTION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 3 | Patient |
| 2024 | Vomiting | 13 | Patient |
| 2024 | Urinary Frequency | 2 | Patient |
| 2024 | Unspecified Tissue Injury | 108 | Patient |
| 2024 | Unspecified Infection | 43 | Patient |
| 2024 | Unintended Radiation Exposure | 1 | Patient |
| 2024 | Ulcer | 1 | Patient |
| 2024 | Tachycardia | 5 | Patient |
| 2024 | Syncope/Fainting | 2 | Patient |
| 2024 | Swelling/ Edema | 19 | Patient |
| 2024 | Stenosis | 1 | Patient |
| 2024 | Sleep Dysfunction | 3 | Patient |
| 2024 | Sexual Dysfunction | 3 | Patient |
| 2024 | Seroma | 31 | Patient |
| 2024 | Sepsis | 3 | Patient |
| 2024 | Scar Tissue | 35 | Patient |
| 2024 | Respiratory Insufficiency | 1 | Patient |
| 2024 | Respiratory Failure | 1 | Patient |
| 2024 | Renal Failure | 6 | Patient |
| 2024 | Rash | 4 | Patient |
| 2024 | Purulent Discharge | 13 | Patient |
| 2024 | Pulmonary Embolism | 1 | Patient |
| 2024 | Pneumonia | 1 | Patient |
| 2024 | Perforation | 25 | Patient |
| 2024 | Pancreatitis | 1 | Patient |
| 2024 | Pain | 58 | Patient |
| 2024 | Obstruction/Occlusion | 51 | Patient |
| 2024 | Numbness | 5 | Patient |
| 2024 | Nodule | 11 | Patient |
| 2024 | Neuropathy | 3 | Patient |
| 2024 | Nerve Damage | 2 | Patient |
| 2024 | Necrosis | 5 | Patient |
| 2024 | Nausea | 13 | Patient |
| 2024 | Muscle Weakness/Atrophy | 8 | Patient |
| 2024 | Malaise | 1 | Patient |
| 2024 | Itching Sensation | 2 | Patient |
| 2024 | Ischemia | 1 | Patient |
| 2024 | Inflammation | 72 | Patient |
| 2024 | Incontinence | 1 | Patient |
| 2024 | Impaired Healing | 22 | Patient |
| 2024 | Hypovolemic Shock | 1 | Patient |
| 2024 | Hypovolemia | 2 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 12 | Patient |
| 2024 | Hypernatremia | 1 | Patient |
| 2024 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2024 | Hernia | 28 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 31 | Patient |
| 2024 | Hematoma | 23 | Patient |
| 2024 | Foreign Body Reaction | 8 | Patient |
| 2024 | Fluid Discharge | 30 | Patient |
| 2024 | Fistula | 31 | Patient |
| 2024 | Fibrosis | 11 | Patient |
| 2024 | Fever | 4 | Patient |
| 2024 | Fatigue | 5 | Patient |
| 2024 | Erythema | 6 | Patient |
| 2024 | Erosion | 7 | Patient |
| 2024 | Emotional Changes | 17 | Patient |
| 2024 | Electrolyte Imbalance | 8 | Patient |
| 2024 | Dysuria | 1 | Patient |
| 2024 | Dysphagia/ Odynophagia | 2 | Patient |
| 2024 | Dyspareunia | 4 | Patient |
| 2024 | Distress | 5 | Patient |
| 2024 | Discomfort | 50 | Patient |
| 2024 | Diarrhea | 8 | Patient |
| 2024 | Diaphoresis | 2 | Patient |
| 2024 | Depression | 14 | Patient |
| 2024 | Dehydration | 3 | Patient |
| 2024 | Deformity/ Disfigurement | 6 | Patient |
| 2024 | Decreased Appetite | 8 | Patient |
| 2024 | Cyst(s) | 1 | Patient |
| 2024 | Cramp(s) /Muscle Spasm(s) | 12 | Patient |
| 2024 | Cough | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Constipation | 12 | Patient |
| 2024 | Confusion/ Disorientation | 1 | Patient |
| 2024 | Chills | 2 | Patient |
| 2024 | Cellulitis | 2 | Patient |
| 2024 | Burning Sensation | 1 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Bruise/Contusion | 1 | Patient |
| 2024 | Blister | 1 | Patient |
| 2024 | Biliary Cirrhosis | 1 | Patient |
| 2024 | Bacterial Infection | 16 | Patient |
| 2024 | Autoimmune Disorder | 2 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Aspiration/Inhalation | 2 | Patient |
| 2024 | Ascites | 13 | Patient |
| 2024 | Appropriate Term / Code Not Available | 54 | Patient |
| 2024 | Anxiety | 4 | Patient |
| 2024 | Anemia | 2 | Patient |
| 2024 | Ambulation Difficulties | 1 | Patient |
| 2024 | Adhesion(s) | 30 | Patient |
| 2024 | Abscess | 5 | Patient |
| 2024 | Abdominal Pain | 28 | Patient |
| 2024 | Abdominal Distention | 28 | Patient |
| 2024 | Product Quality Problem | 2 | Device |
| 2024 | Patient-Device Incompatibility | 3 | Device |
| 2024 | Patient Device Interaction Problem | 113 | Device |
| 2024 | Migration or Expulsion of Device | 99 | Device |
| 2024 | Mechanics Altered | 54 | Device |
| 2024 | Material Split, Cut or Torn | 15 | Device |
| 2024 | Material Perforation | 6 | Device |
| 2024 | Material Integrity Problem | 14 | Device |
| 2024 | Material Erosion | 16 | Device |
| 2024 | Material Deformation | 22 | Device |
| 2024 | Loss of or Failure to Bond | 24 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Human-Device Interface Problem | 2 | Device |
| 2024 | Failure To Adhere Or Bond | 1 | Device |
| 2024 | Entrapment of Device | 2 | Device |
| 2024 | Detachment of Device or Device Component | 6 | Device |
| 2024 | Degraded | 7 | Device |
| 2024 | Defective Device | 2 | Device |
| 2024 | Appropriate Term/Code Not Available | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 287 | Device |
| 2023 | Wound Dehiscence | 4 | Patient |
| 2023 | Weight Changes | 3 | Patient |
| 2023 | Vomiting | 17 | Patient |
| 2023 | Urinary Tract Infection | 1 | Patient |
| 2023 | Urinary Retention | 1 | Patient |
| 2023 | Urinary Frequency | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 164 | Patient |
| 2023 | Unspecified Infection | 45 | Patient |
| 2023 | Ulcer | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 5 | Patient |
| 2023 | Tachycardia | 2 | Patient |
| 2023 | Syncope/Fainting | 2 | Patient |
| 2023 | Swelling/ Edema | 29 | Patient |
| 2023 | Solid Tumour | 2 | Patient |
| 2023 | Sleep Dysfunction | 3 | Patient |
| 2023 | Shaking/Tremors | 1 | Patient |
| 2023 | Sexual Dysfunction | 7 | Patient |
| 2023 | Seroma | 65 | Patient |
| 2023 | Sepsis | 5 | Patient |
| 2023 | Scar Tissue | 52 | Patient |
| 2023 | Respiratory Failure | 4 | Patient |
| 2023 | Respiratory Acidosis | 1 | Patient |
| 2023 | Renal Failure | 5 | Patient |
| 2023 | Purulent Discharge | 12 | Patient |
| 2023 | Pulmonary Emphysema | 1 | Patient |
| 2023 | Pneumothorax | 1 | Patient |
| 2023 | Pneumonia | 3 | Patient |
| 2023 | Pleural Effusion | 1 | Patient |
| 2023 | Peritonitis | 3 | Patient |
| 2023 | Perforation | 39 | Patient |
| 2023 | Pancreatitis | 2 | Patient |
| 2023 | Pain | 68 | Patient |
| 2023 | Obstruction/Occlusion | 59 | Patient |
| 2023 | Numbness | 3 | Patient |
| 2023 | Nodule | 17 | Patient |
| 2023 | Nerve Damage | 3 | Patient |
| 2023 | Necrosis | 7 | Patient |
| 2023 | Nausea | 21 | Patient |
| 2023 | Muscle Weakness/Atrophy | 17 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Local Reaction | 1 | Patient |
| 2023 | Itching Sensation | 1 | Patient |
| 2023 | Ischemia | 2 | Patient |
| 2023 | Inflammation | 112 | Patient |
| 2023 | Incontinence | 1 | Patient |
| 2023 | Impaired Healing | 23 | Patient |
| 2023 | Hypoxia | 2 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 13 | Patient |
| 2023 | Hyperplasia | 1 | Patient |
| 2023 | Hypernatremia | 1 | Patient |
| 2023 | Hot Flashes/Flushes | 1 | Patient |
| 2023 | Hernia | 57 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 58 | Patient |
| 2023 | Hematoma | 36 | Patient |
| 2023 | Heartburn/Indigestion | 3 | Patient |
| 2023 | Headache | 2 | Patient |
| 2023 | Hair Loss | 2 | Patient |
| 2023 | Gastritis | 3 | Patient |
| 2023 | Foreign Body Reaction | 10 | Patient |
| 2023 | Fluid Discharge | 47 | Patient |
| 2023 | Fistula | 19 | Patient |
| 2023 | Fibrosis | 9 | Patient |
| 2023 | Fever | 8 | Patient |
| 2023 | Fatigue | 3 | Patient |
| 2023 | Erythema | 12 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Emotional Changes | 29 | Patient |
| 2023 | Electrolyte Imbalance | 4 | Patient |
| 2023 | Ecchymosis | 1 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Dysphagia/ Odynophagia | 2 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Distress | 21 | Patient |
| 2023 | Discomfort | 47 | Patient |
| 2023 | Diarrhea | 9 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Depression | 28 | Patient |
| 2023 | Dehydration | 2 | Patient |
| 2023 | Deformity/ Disfigurement | 12 | Patient |
| 2023 | Decreased Appetite | 7 | Patient |
| 2023 | Cyst(s) | 1 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 11 | Patient |
| 2023 | Cough | 1 | Patient |
| 2023 | Constipation | 15 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Cellulitis | 5 | Patient |
| 2023 | Burning Sensation | 2 | Patient |
| 2023 | Bruise/Contusion | 1 | Patient |
| 2023 | Bowel Perforation | 1 | Patient |
| 2023 | Bacterial Infection | 16 | Patient |
| 2023 | Autoimmune Disorder | 2 | Patient |
| 2023 | Ascites | 17 | Patient |
| 2023 | Appropriate Term / Code Not Available | 109 | Patient |
| 2023 | Anxiety | 12 | Patient |
| 2023 | Ambulation Difficulties | 9 | Patient |
| 2023 | Adhesion(s) | 51 | Patient |
| 2023 | Abscess | 22 | Patient |
| 2023 | Abdominal Pain | 48 | Patient |
| 2023 | Abdominal Distention | 46 | Patient |
| 2023 | Abdominal Cramps | 2 | Patient |
| 2023 | Torn Material | 1 | Device |
| 2023 | Product Quality Problem | 2 | Device |
| 2023 | Physical Resistance/Sticking | 1 | Device |
| 2023 | Patient-Device Incompatibility | 9 | Device |
| 2023 | Patient Device Interaction Problem | 187 | Device |
| 2023 | Migration or Expulsion of Device | 184 | Device |
| 2023 | Mechanics Altered | 135 | Device |
| 2023 | Material Split, Cut or Torn | 30 | Device |
| 2023 | Material Rupture | 1 | Device |
| 2023 | Material Perforation | 13 | Device |
| 2023 | Material Integrity Problem | 18 | Device |
| 2023 | Material Erosion | 36 | Device |
| 2023 | Material Deformation | 30 | Device |
| 2023 | Loss of or Failure to Bond | 35 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Degraded | 21 | Device |
| 2023 | Defective Device | 7 | Device |
| 2023 | Defective Component | 2 | Device |
| 2023 | Contamination | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 5 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 509 | Device |
| 2022 | Vomiting | 1 | Patient |
| 2022 | Seroma | 1 | Patient |
| 2022 | Scar Tissue | 1 | Patient |
| 2022 | Perforation | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Nausea | 1 | Patient |
| 2022 | Muscle Weakness/Atrophy | 2 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Diarrhea | 1 | Patient |
| 2022 | Adhesion(s) | 2 | Patient |
| 2022 | Abscess | 1 | Patient |
| 2022 | Abdominal Pain | 1 | Patient |
| 2022 | Abdominal Distention | 1 | Patient |
| 2022 | Product Quality Problem | 1 | Device |
| 2022 | Patient-Device Incompatibility | 3 | Device |
| 2022 | Patient Device Interaction Problem | 137 | Device |
| 2022 | Migration or Expulsion of Device | 129 | Device |
| 2022 | Mechanics Altered | 36 | Device |
| 2022 | Material Split, Cut or Torn | 20 | Device |
| 2022 | Material Protrusion/Extrusion | 1 | Device |
| 2022 | Material Perforation | 13 | Device |
| 2022 | Material Integrity Problem | 14 | Device |
| 2022 | Material Fragmentation | 1 | Device |
| 2022 | Material Erosion | 14 | Device |
| 2022 | Material Deformation | 22 | Device |
| 2022 | Loss of or Failure to Bond | 37 | Device |
| 2022 | Insufficient Information | 3 | Device |
| 2022 | Entrapment of Device | 2 | Device |
| 2022 | Detachment of Device or Device Component | 5 | Device |
| 2022 | Degraded | 11 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 279 | Device |
| 2021 | Suicidal Ideation | 1 | Patient |
| 2021 | Obstruction/Occlusion | 1 | Patient |
| 2021 | Nausea | 1 | Patient |
| 2021 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2021 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2021 | Foreign Body Reaction | 1 | Patient |
| 2021 | Diarrhea | 1 | Patient |
| 2021 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2021 | Constipation | 1 | Patient |
| 2021 | Adhesion(s) | 1 | Patient |
| 2021 | Abdominal Pain | 1 | Patient |
| 2021 | Abdominal Distention | 1 | Patient |
| 2021 | Patient-Device Incompatibility | 2 | Device |
| 2021 | Patient Device Interaction Problem | 37 | Device |
| 2021 | Migration or Expulsion of Device | 33 | Device |
| 2021 | Mechanics Altered | 37 | Device |
| 2021 | Material Split, Cut or Torn | 5 | Device |
| 2021 | Material Perforation | 1 | Device |
| 2021 | Material Integrity Problem | 10 | Device |
| 2021 | Material Erosion | 3 | Device |
| 2021 | Material Deformation | 3 | Device |
| 2021 | Loss of or Failure to Bond | 8 | Device |
| 2021 | Insufficient Information | 3 | Device |
| 2021 | Entrapment of Device | 1 | Device |
| 2021 | Degraded | 2 | Device |
| 2021 | Defective Device | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 95 | Device |
| 2020 | Unspecified Tissue Injury | 4 | Patient |
| 2020 | Unspecified Heart Problem | 1 | Patient |
| 2020 | Swelling/ Edema | 2 | Patient |
| 2020 | Scar Tissue | 1 | Patient |
| 2020 | Pulmonary Edema | 1 | Patient |
| 2020 | Pain | 1 | Patient |
| 2020 | Muscle Weakness/Atrophy | 1 | Patient |
| 2020 | Inflammation | 1 | Patient |
| 2020 | Impaired Healing | 1 | Patient |
| 2020 | Fluid Discharge | 3 | Patient |
| 2020 | Fistula | 1 | Patient |
| 2020 | Constipation | 1 | Patient |
| 2020 | Cellulitis | 1 | Patient |
| 2020 | Bacterial Infection | 2 | Patient |
| 2020 | Appropriate Term / Code Not Available | 4 | Patient |
| 2020 | Abscess | 1 | Patient |
| 2020 | Abdominal Pain | 1 | Patient |
| 2020 | Product Quality Problem | 2 | Device |
| 2020 | Patient-Device Incompatibility | 2 | Device |
| 2020 | Patient Device Interaction Problem | 12 | Device |
| 2020 | Migration or Expulsion of Device | 8 | Device |
| 2020 | Material Split, Cut or Torn | 3 | Device |
| 2020 | Material Perforation | 1 | Device |
| 2020 | Material Integrity Problem | 1 | Device |
| 2020 | Material Erosion | 2 | Device |
| 2020 | Material Deformation | 2 | Device |
| 2020 | Loss of or Failure to Bond | 4 | Device |
| 2020 | Insufficient Information | 2 | Device |
| 2020 | Detachment of Device or Device Component | 1 | Device |
| 2020 | Defective Device | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 63 | Device |