DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
This device is manufactured by AMERICAN MEDICAL SYSTEMS, BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 2 | Patient |
| 2024 | Urethral Stenosis/Stricture | 1 | Patient |
| 2024 | Unspecified Tissue Injury | 2 | Patient |
| 2024 | Unspecified Infection | 19 | Patient |
| 2024 | Swelling/ Edema | 6 | Patient |
| 2024 | Skin Inflammation/ Irritation | 1 | Patient |
| 2024 | Rash | 1 | Patient |
| 2024 | Purulent Discharge | 2 | Patient |
| 2024 | Perforation | 4 | Patient |
| 2024 | Pain | 16 | Patient |
| 2024 | Necrosis | 1 | Patient |
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Implant Pain | 1 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Hematoma | 2 | Patient |
| 2024 | Fluid Discharge | 2 | Patient |
| 2024 | Erosion | 17 | Patient |
| 2024 | Erectile Dysfunction | 1 | Patient |
| 2024 | Discomfort | 11 | Patient |
| 2024 | Cellulitis | 1 | Patient |
| 2024 | Burning Sensation | 1 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Adhesion(s) | 1 | Patient |
| 2024 | Unintended Deflation | 1 | Device |
| 2024 | Migration | 21 | Device |
| 2024 | Mechanical Problem | 40 | Device |
| 2024 | Material Puncture/Hole | 26 | Device |
| 2024 | Material Discolored | 1 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Malposition of Device | 8 | Device |
| 2024 | Insufficient Information | 5 | Device |
| 2024 | Inflation Problem | 41 | Device |
| 2024 | Inadequacy of Device Shape and/or Size | 5 | Device |
| 2024 | Fluid/Blood Leak | 42 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2024 | Device Contaminated During Manufacture or Shipping | 2 | Device |
| 2024 | Degraded | 7 | Device |
| 2024 | Deflation Problem | 9 | Device |
| 2024 | Defective Device | 6 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Collapse | 3 | Device |
| 2024 | Air/Gas in Device | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Urinary Retention | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 4 | Patient |
| 2023 | Unspecified Infection | 32 | Patient |
| 2023 | Swelling/ Edema | 7 | Patient |
| 2023 | Seroma | 1 | Patient |
| 2023 | Scar Tissue | 5 | Patient |
| 2023 | Purulent Discharge | 1 | Patient |
| 2023 | Perforation | 6 | Patient |
| 2023 | Pain | 21 | Patient |
| 2023 | Numbness | 1 | Patient |
| 2023 | Insufficient Information | 6 | Patient |
| 2023 | Inflammation | 2 | Patient |
| 2023 | Impaired Healing | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Hernia | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Hematoma | 3 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fistula | 2 | Patient |
| 2023 | Erosion | 19 | Patient |
| 2023 | Dysuria | 1 | Patient |
| 2023 | Discomfort | 14 | Patient |
| 2023 | Deformity/ Disfigurement | 1 | Patient |
| 2023 | Capsular Contracture | 2 | Patient |
| 2023 | Burning Sensation | 2 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Adhesion(s) | 3 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Abdominal Pain | 2 | Patient |
| 2023 | Unintended Deflation | 3 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Migration | 26 | Device |
| 2023 | Mechanical Problem | 60 | Device |
| 2023 | Material Puncture/Hole | 42 | Device |
| 2023 | Material Deformation | 2 | Device |
| 2023 | Malposition of Device | 13 | Device |
| 2023 | Insufficient Information | 5 | Device |
| 2023 | Inflation Problem | 96 | Device |
| 2023 | Inadequacy of Device Shape and/or Size | 8 | Device |
| 2023 | Fluid/Blood Leak | 63 | Device |
| 2023 | Failure to Deflate | 3 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2023 | Device Contaminated During Manufacture or Shipping | 2 | Device |
| 2023 | Degraded | 6 | Device |
| 2023 | Deflation Problem | 18 | Device |
| 2023 | Defective Device | 9 | Device |
| 2023 | Connection Problem | 3 | Device |
| 2023 | Collapse | 12 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Air/Gas in Device | 7 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 74 | Device |
| 2022 | Wound Dehiscence | 1 | Patient |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Perforation | 4 | Patient |
| 2022 | Pain | 3 | Patient |
| 2022 | Erosion | 2 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Unintended Deflation | 2 | Device |
| 2022 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2022 | Migration | 27 | Device |
| 2022 | Mechanical Problem | 55 | Device |
| 2022 | Material Puncture/Hole | 47 | Device |
| 2022 | Material Deformation | 2 | Device |
| 2022 | Malposition of Device | 18 | Device |
| 2022 | Insufficient Information | 4 | Device |
| 2022 | Inflation Problem | 61 | Device |
| 2022 | Inadequacy of Device Shape and/or Size | 9 | Device |
| 2022 | Fluid/Blood Leak | 50 | Device |
| 2022 | Difficult or Delayed Activation | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2022 | Degraded | 5 | Device |
| 2022 | Deflation Problem | 8 | Device |
| 2022 | Defective Device | 10 | Device |
| 2022 | Collapse | 13 | Device |
| 2022 | Air/Gas in Device | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 61 | Device |
| 2021 | Migration | 1 | Device |
| 2021 | Mechanical Problem | 5 | Device |
| 2021 | Material Puncture/Hole | 1 | Device |
| 2021 | Inflation Problem | 4 | Device |
| 2021 | Fluid/Blood Leak | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Erosion | 1 | Patient |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Inflation Problem | 4 | Device |
| 2020 | Deflation Problem | 1 | Device |
| 2020 | Collapse | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |