MESH, SURGICAL, POLYMERIC
This device is manufactured by SOFRADIM PRODUCTION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vomiting | 2 | Patient |
| 2024 | Urinary Retention | 1 | Patient |
| 2024 | Urinary Incontinence | 2 | Patient |
| 2024 | Unspecified Tissue Injury | 166 | Patient |
| 2024 | Unspecified Infection | 17 | Patient |
| 2024 | Twitching | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Swelling/ Edema | 24 | Patient |
| 2024 | Suicidal Ideation | 1 | Patient |
| 2024 | Sleep Dysfunction | 1 | Patient |
| 2024 | Skin Inflammation/ Irritation | 1 | Patient |
| 2024 | Sexual Dysfunction | 4 | Patient |
| 2024 | Seroma | 17 | Patient |
| 2024 | Septic Shock | 2 | Patient |
| 2024 | Scar Tissue | 48 | Patient |
| 2024 | Respiratory Failure | 3 | Patient |
| 2024 | Renal Failure | 3 | Patient |
| 2024 | Purulent Discharge | 2 | Patient |
| 2024 | Perforation | 5 | Patient |
| 2024 | Paresthesia | 1 | Patient |
| 2024 | Pain | 63 | Patient |
| 2024 | Obstruction/Occlusion | 12 | Patient |
| 2024 | Numbness | 4 | Patient |
| 2024 | Nodule | 16 | Patient |
| 2024 | Neuralgia | 3 | Patient |
| 2024 | Nerve Damage | 12 | Patient |
| 2024 | Necrosis | 4 | Patient |
| 2024 | Nausea | 6 | Patient |
| 2024 | Muscle Weakness/Atrophy | 8 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Ischemia | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Inflammation | 33 | Patient |
| 2024 | Increased Sensitivity | 1 | Patient |
| 2024 | Impaired Healing | 6 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 3 | Patient |
| 2024 | Hernia | 75 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 11 | Patient |
| 2024 | Hemoptysis | 1 | Patient |
| 2024 | Hematoma | 9 | Patient |
| 2024 | Foreign Body Reaction | 10 | Patient |
| 2024 | Fluid Discharge | 9 | Patient |
| 2024 | Fistula | 4 | Patient |
| 2024 | Fibrosis | 3 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Erythema | 3 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Emotional Changes | 34 | Patient |
| 2024 | Dysuria | 5 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Dyspareunia | 2 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Distress | 85 | Patient |
| 2024 | Discomfort | 17 | Patient |
| 2024 | Diarrhea | 3 | Patient |
| 2024 | Deformity/ Disfigurement | 1 | Patient |
| 2024 | Decreased Appetite | 3 | Patient |
| 2024 | Cramp(s) /Muscle Spasm(s) | 7 | Patient |
| 2024 | Constipation | 4 | Patient |
| 2024 | Chills | 3 | Patient |
| 2024 | Cellulitis | 1 | Patient |
| 2024 | Burning Sensation | 3 | Patient |
| 2024 | Biliary Cirrhosis | 2 | Patient |
| 2024 | Bacterial Infection | 2 | Patient |
| 2024 | Ascites | 6 | Patient |
| 2024 | Appropriate Term / Code Not Available | 37 | Patient |
| 2024 | Anxiety | 3 | Patient |
| 2024 | Ambulation Difficulties | 4 | Patient |
| 2024 | Adhesion(s) | 41 | Patient |
| 2024 | Abscess | 3 | Patient |
| 2024 | Abdominal Pain | 15 | Patient |
| 2024 | Abdominal Distention | 8 | Patient |
| 2024 | Product Quality Problem | 1 | Device |
| 2024 | Patient Device Interaction Problem | 19 | Device |
| 2024 | Migration or Expulsion of Device | 54 | Device |
| 2024 | Mechanics Altered | 108 | Device |
| 2024 | Material Split, Cut or Torn | 7 | Device |
| 2024 | Material Perforation | 4 | Device |
| 2024 | Material Integrity Problem | 8 | Device |
| 2024 | Material Erosion | 5 | Device |
| 2024 | Material Deformation | 8 | Device |
| 2024 | Loss of or Failure to Bond | 2 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Human-Device Interface Problem | 1 | Device |
| 2024 | Degraded | 7 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 206 | Device |
| 2023 | Wound Dehiscence | 2 | Patient |
| 2023 | Vomiting | 15 | Patient |
| 2023 | Vasoconstriction | 1 | Patient |
| 2023 | Urinary Tract Infection | 1 | Patient |
| 2023 | Urinary Retention | 5 | Patient |
| 2023 | Urinary Frequency | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 130 | Patient |
| 2023 | Unspecified Infection | 28 | Patient |
| 2023 | Ulcer | 3 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2023 | Swelling/ Edema | 20 | Patient |
| 2023 | Stenosis | 1 | Patient |
| 2023 | Solid Tumour | 1 | Patient |
| 2023 | Sleep Dysfunction | 2 | Patient |
| 2023 | Skin Discoloration | 2 | Patient |
| 2023 | Shaking/Tremors | 2 | Patient |
| 2023 | Sexual Dysfunction | 5 | Patient |
| 2023 | Seroma | 26 | Patient |
| 2023 | Sepsis | 2 | Patient |
| 2023 | Scar Tissue | 85 | Patient |
| 2023 | Respiratory Insufficiency | 1 | Patient |
| 2023 | Respiratory Failure | 2 | Patient |
| 2023 | Purulent Discharge | 8 | Patient |
| 2023 | Prolapse | 4 | Patient |
| 2023 | Pneumonia | 2 | Patient |
| 2023 | Pleural Effusion | 1 | Patient |
| 2023 | Perforation | 2 | Patient |
| 2023 | Paresthesia | 3 | Patient |
| 2023 | Pain | 73 | Patient |
| 2023 | Obstruction/Occlusion | 30 | Patient |
| 2023 | Numbness | 10 | Patient |
| 2023 | Nodule | 15 | Patient |
| 2023 | Neuropathy | 6 | Patient |
| 2023 | Nerve Damage | 26 | Patient |
| 2023 | Necrosis | 9 | Patient |
| 2023 | Nausea | 20 | Patient |
| 2023 | Muscle Weakness/Atrophy | 12 | Patient |
| 2023 | Itching Sensation | 1 | Patient |
| 2023 | Ischemia | 1 | Patient |
| 2023 | Inflammation | 50 | Patient |
| 2023 | Increased Sensitivity | 1 | Patient |
| 2023 | Incontinence | 1 | Patient |
| 2023 | Impaired Healing | 7 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 4 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 2 | Patient |
| 2023 | Hernia | 90 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 15 | Patient |
| 2023 | Hematoma | 16 | Patient |
| 2023 | Granuloma | 3 | Patient |
| 2023 | Foreign Body Reaction | 17 | Patient |
| 2023 | Fluid Discharge | 10 | Patient |
| 2023 | Fistula | 6 | Patient |
| 2023 | Fibrosis | 18 | Patient |
| 2023 | Fever | 7 | Patient |
| 2023 | Fatigue | 2 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Erythema | 9 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Emotional Changes | 55 | Patient |
| 2023 | Electrolyte Imbalance | 1 | Patient |
| 2023 | Dysuria | 2 | Patient |
| 2023 | Dyspnea | 3 | Patient |
| 2023 | Dyspareunia | 4 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Distress | 48 | Patient |
| 2023 | Discomfort | 40 | Patient |
| 2023 | Diarrhea | 3 | Patient |
| 2023 | Diaphoresis | 2 | Patient |
| 2023 | Dehydration | 1 | Patient |
| 2023 | Deformity/ Disfigurement | 5 | Patient |
| 2023 | Decreased Appetite | 1 | Patient |
| 2023 | Cyst(s) | 2 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2023 | Constipation | 7 | Patient |
| 2023 | Chills | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cellulitis | 2 | Patient |
| 2023 | Burning Sensation | 4 | Patient |
| 2023 | Blurred Vision | 2 | Patient |
| 2023 | Bacterial Infection | 4 | Patient |
| 2023 | Ascites | 15 | Patient |
| 2023 | Appropriate Term / Code Not Available | 58 | Patient |
| 2023 | Anxiety | 7 | Patient |
| 2023 | Anemia | 1 | Patient |
| 2023 | Ambulation Difficulties | 2 | Patient |
| 2023 | Adhesion(s) | 78 | Patient |
| 2023 | Abscess | 14 | Patient |
| 2023 | Abdominal Pain | 42 | Patient |
| 2023 | Abdominal Distention | 27 | Patient |
| 2023 | Abdominal Cramps | 1 | Patient |
| 2023 | Product Quality Problem | 2 | Device |
| 2023 | Patient-Device Incompatibility | 1 | Device |
| 2023 | Patient Device Interaction Problem | 29 | Device |
| 2023 | Migration or Expulsion of Device | 73 | Device |
| 2023 | Mechanics Altered | 152 | Device |
| 2023 | Material Split, Cut or Torn | 7 | Device |
| 2023 | Material Perforation | 1 | Device |
| 2023 | Material Integrity Problem | 12 | Device |
| 2023 | Material Erosion | 3 | Device |
| 2023 | Material Deformation | 11 | Device |
| 2023 | Loss of or Failure to Bond | 8 | Device |
| 2023 | Insufficient Information | 3 | Device |
| 2023 | Failure to Unfold or Unwrap | 1 | Device |
| 2023 | Difficult to Remove | 2 | Device |
| 2023 | Degraded | 4 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 249 | Device |
| 2022 | Tissue Breakdown | 1 | Patient |
| 2022 | Perforation | 1 | Patient |
| 2022 | Incontinence | 1 | Patient |
| 2022 | Hernia | 2 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Ambulation Difficulties | 1 | Patient |
| 2022 | Patient Device Interaction Problem | 8 | Device |
| 2022 | Migration or Expulsion of Device | 36 | Device |
| 2022 | Mechanics Altered | 64 | Device |
| 2022 | Material Split, Cut or Torn | 5 | Device |
| 2022 | Material Perforation | 1 | Device |
| 2022 | Material Integrity Problem | 3 | Device |
| 2022 | Material Deformation | 5 | Device |
| 2022 | Loss of or Failure to Bond | 4 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Degraded | 5 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 84 | Device |
| 2021 | Product Quality Problem | 1 | Device |
| 2021 | Patient Device Interaction Problem | 3 | Device |
| 2021 | Migration or Expulsion of Device | 7 | Device |
| 2021 | Mechanics Altered | 26 | Device |
| 2021 | Material Integrity Problem | 4 | Device |
| 2021 | Material Deformation | 2 | Device |
| 2021 | Loss of or Failure to Bond | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Detachment of Device or Device Component | 1 | Device |
| 2021 | Degraded | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2020 | Unspecified Tissue Injury | 4 | Patient |
| 2020 | Unspecified Heart Problem | 2 | Patient |
| 2020 | Tissue Breakdown | 1 | Patient |
| 2020 | Scar Tissue | 2 | Patient |
| 2020 | Pain | 2 | Patient |
| 2020 | Muscle Weakness/Atrophy | 2 | Patient |
| 2020 | Inflammation | 2 | Patient |
| 2020 | Hernia | 3 | Patient |
| 2020 | Fluid Discharge | 1 | Patient |
| 2020 | Failure of Implant | 1 | Patient |
| 2020 | Constipation | 4 | Patient |
| 2020 | Appropriate Term / Code Not Available | 4 | Patient |
| 2020 | Abdominal Pain | 2 | Patient |
| 2020 | Abdominal Distention | 1 | Patient |
| 2020 | Unintended Movement | 1 | Device |
| 2020 | Patient-Device Incompatibility | 6 | Device |
| 2020 | Patient Device Interaction Problem | 14 | Device |
| 2020 | Migration or Expulsion of Device | 30 | Device |
| 2020 | Material Split, Cut or Torn | 6 | Device |
| 2020 | Material Integrity Problem | 1 | Device |
| 2020 | Material Erosion | 3 | Device |
| 2020 | Material Deformation | 2 | Device |
| 2020 | Loss of or Failure to Bond | 6 | Device |
| 2020 | Insufficient Information | 2 | Device |
| 2020 | Human-Device Interface Problem | 1 | Device |
| 2020 | Degraded | 4 | Device |
| 2020 | Defective Device | 1 | Device |
| 2020 | Defective Component | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 6 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 165 | Device |