SOFRADIM SUPPORT KIT
This device is manufactured by SOFRADIM PRODUCTION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2014 | Insufficient Information | 1 | Device |
| 2014 | Fluid/Blood Leak | 1 | Device |
| 2009 | Insufficient Information | 1 | Device |
| 2008 | Device Operates Differently Than Expected | 1 | Device |
| 2008 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2007 | Insufficient Information | 3 | Device |
| 2006 | Prolapse | 1 | Patient |
| 2006 | Incontinence | 1 | Patient |
| 2006 | Decreased Respiratory Rate | 1 | Patient |
| 2006 | Insufficient Information | 7 | Device |
| 2006 | Device Operates Differently Than Expected | 1 | Device |
| 2005 | Device Operates Differently Than Expected | 1 | Device |
| 2004 | Insufficient Information | 1 | Device |
| 2004 | Device Operates Differently Than Expected | 2 | Device |
| 2004 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2003 | Material Erosion | 1 | Device |
| 2003 | Insufficient Information | 1 | Device |
| 2003 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2002 | Insufficient Information | 1 | Device |
| 2002 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2001 | Device Operates Differently Than Expected | 1 | Device |