UNO EWIS BLUE 60/6 HCAP 1-PK INT
This device is manufactured by UNOMEDICAL A/S.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Skin Inflammation/ Irritation | 10 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Pain | 8 | Patient |
| 2024 | Hypoglycemia | 6 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 2 | Patient |
| 2024 | Hyperglycemia | 49 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 12 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Packaging Problem | 1 | Device |
| 2024 | No Apparent Adverse Event | 15 | Device |
| 2024 | Material Twisted/Bent | 47 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Loss of or Failure to Bond | 297 | Device |
| 2024 | Leak/Splash | 107 | Device |
| 2024 | Infusion or Flow Problem | 25 | Device |
| 2024 | Device Handling Problem | 3 | Device |
| 2024 | Detachment of Device or Device Component | 24 | Device |
| 2024 | Crack | 1 | Device |
| 2023 | Hyperglycemia | 3 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2023 | Material Twisted/Bent | 1 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Loss of or Failure to Bond | 3 | Device |
| 2023 | Leak/Splash | 6 | Device |
| 2023 | Detachment of Device or Device Component | 11 | Device |
| 2022 | Hyperglycemia | 3 | Patient |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Detachment of Device or Device Component | 10 | Device |