DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
This device is manufactured by BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 10 | Patient |
| 2024 | Swelling/ Edema | 5 | Patient |
| 2024 | Scar Tissue | 3 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Pain | 10 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Fibrosis | 1 | Patient |
| 2024 | Erythema | 1 | Patient |
| 2024 | Erosion | 9 | Patient |
| 2024 | Discomfort | 6 | Patient |
| 2024 | Capsular Contracture | 1 | Patient |
| 2024 | Adhesion(s) | 1 | Patient |
| 2024 | Unintended Deflation | 1 | Device |
| 2024 | Migration | 7 | Device |
| 2024 | Mechanical Problem | 68 | Device |
| 2024 | Material Puncture/Hole | 54 | Device |
| 2024 | Material Deformation | 4 | Device |
| 2024 | Malposition of Device | 5 | Device |
| 2024 | Insufficient Information | 3 | Device |
| 2024 | Inflation Problem | 32 | Device |
| 2024 | Inadequacy of Device Shape and/or Size | 8 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Fluid/Blood Leak | 42 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Deflation Problem | 4 | Device |
| 2024 | Defective Device | 9 | Device |
| 2024 | Collapse | 5 | Device |
| 2024 | Air/Gas in Device | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Unspecified Infection | 9 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Shock | 1 | Patient |
| 2023 | Scar Tissue | 1 | Patient |
| 2023 | Purulent Discharge | 3 | Patient |
| 2023 | Perforation | 2 | Patient |
| 2023 | Pain | 4 | Patient |
| 2023 | Insufficient Information | 8 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Erosion | 7 | Patient |
| 2023 | Erectile Dysfunction | 1 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Deformity/ Disfigurement | 1 | Patient |
| 2023 | Cellulitis | 1 | Patient |
| 2023 | Migration | 10 | Device |
| 2023 | Mechanical Problem | 89 | Device |
| 2023 | Material Puncture/Hole | 68 | Device |
| 2023 | Malposition of Device | 10 | Device |
| 2023 | Insufficient Information | 8 | Device |
| 2023 | Inflation Problem | 35 | Device |
| 2023 | Inadequacy of Device Shape and/or Size | 7 | Device |
| 2023 | Fluid/Blood Leak | 43 | Device |
| 2023 | Failure to Deflate | 1 | Device |
| 2023 | Degraded | 3 | Device |
| 2023 | Deflation Problem | 3 | Device |
| 2023 | Defective Device | 10 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Collapse | 16 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Air/Gas in Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 37 | Device |
| 2022 | Unspecified Infection | 6 | Patient |
| 2022 | Purulent Discharge | 1 | Patient |
| 2022 | Inflammation | 3 | Patient |
| 2022 | Fluid Discharge | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Migration | 4 | Device |
| 2022 | Mechanical Problem | 69 | Device |
| 2022 | Material Puncture/Hole | 63 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Malposition of Device | 4 | Device |
| 2022 | Insufficient Information | 6 | Device |
| 2022 | Inflation Problem | 20 | Device |
| 2022 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Fluid/Blood Leak | 19 | Device |
| 2022 | Failure to Deflate | 1 | Device |
| 2022 | Degraded | 4 | Device |
| 2022 | Deflation Problem | 4 | Device |
| 2022 | Defective Device | 4 | Device |
| 2022 | Collapse | 11 | Device |
| 2022 | Air/Gas in Device | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 45 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Mechanical Problem | 2 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Inflation Problem | 1 | Device |
| 2021 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Mechanical Problem | 3 | Device |
| 2020 | Inflation Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |