DRESSING,WOUND,OCCLUSIVE
This device is manufactured by CONVATEC DOMINICAN REPUBLIC.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unsealed Device Packaging | 1 | Device |
| 2024 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2024 | Packaging Problem | 7 | Device |
| 2024 | Nonstandard Device | 5 | Device |
| 2024 | Device Damaged Prior to Use | 2 | Device |
| 2024 | Delivered as Unsterile Product | 330 | Device |
| 2024 | Contamination /Decontamination Problem | 327 | Device |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Unsealed Device Packaging | 69 | Device |
| 2023 | Tear, Rip or Hole in Device Packaging | 2 | Device |
| 2023 | Packaging Problem | 72 | Device |
| 2023 | Microbial Contamination of Device | 4 | Device |
| 2023 | Material Discolored | 4 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2023 | Difficult to Remove | 2 | Device |
| 2023 | Device Damaged Prior to Use | 72 | Device |
| 2023 | Delivered as Unsterile Product | 1035 | Device |
| 2023 | Contamination /Decontamination Problem | 963 | Device |
| 2022 | Unsealed Device Packaging | 9 | Device |
| 2022 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2022 | Separation Problem | 1 | Device |
| 2022 | Packaging Problem | 11 | Device |
| 2022 | Material Separation | 1 | Device |
| 2022 | Difficult to Remove | 5 | Device |
| 2022 | Device Contaminated During Manufacture or Shipping | 5 | Device |
| 2022 | Delivered as Unsterile Product | 27 | Device |
| 2022 | Contamination /Decontamination Problem | 18 | Device |
| 2022 | Activation, Positioning or Separation Problem | 1 | Device |